Injection training apparatus using 3D position sensor

ABSTRACT

Systems and methods are disclosed for an apparatus and method for practicing injection techniques through an injectable apparatus. The injectable apparatus may contain a camera that is configured to provide three-dimensional location information for a testing tool based on light attenuated from the testing tool after it is injected into a simulated human or animal body parts. A training tool may be connected to a user display device to generate a display of the injection apparatus as well as the performance parameters of a trainee.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 14/067,829 filed on Oct. 30, 2013 which claims the benefit ofU.S. Provisional Applications Nos. 61/720,046, filed on Oct. 30, 2012;61/784,239, filed on Mar. 14, 2013; 61/814,766, filed on Apr. 22, 2013;and 61/826,899, filed on May 23, 2013, the entirety of which are herebyincorporated herein by reference.

This application also claims the priority benefit of U.S. ProvisionalApplication No. 61/939,093 filed on Feb. 12, 2014, the entirety of whichis hereby incorporated herein by reference.

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are also hereby incorporated by reference under37 C.F.R. §1.57.

BACKGROUND

A variety of medical injection procedures are often performed inprophylactic, curative, therapeutic, or cosmetic treatments. Injectionsmay be administered in various locations on the body, such as under theconjunctiva, into arteries, bone marrow, the spine, the sternum, thepleural space of the chest region, the peritoneal cavity, joint spaces,and internal organs. Injections can also be helpful in administeringmedication directly into anatomic locations that are generating pain.These injections may be administered intravenously (through the vein),intramuscularly (into the muscle), intradermally (beneath the skin),subcutaneously (into the fatty layer of skin) or intraperitonealinjections (into the body cavity). Injections can be performed on humansas well as animals. The methods of administering injections typicallyrange for different procedures and may depend on the substance beinginjected, needle size, or area of injection.

Injections are not limited to treating medical conditions, but may beexpanded to treating aesthetic imperfections or restorative cosmeticprocedures. Many of these procedures are performed through injections ofvarious products into different parts of the body. The aesthetics andtherapeutic industry consists of two main categories of injectableproducts: neuromodulators and dermal fillers. The neuromodulatorindustry commonly utilizes nerve-inhibiting products such as Botox®,Dysport®, and Xeomin®. The dermal filler industry utilizes productsadministered by providers to patients for both cosmetic and therapeuticreasons, such as, for example, Juvederm®, Restylane®, Belotero®,Sculptra®, Artefill®, and others. These providers or injectors mayinclude plastic surgeons, facial plastic surgeons, oculoplasticsurgeons, dermatologists, nurse practitioners, dentists and nurses.

SUMMARY

One of the major problems in the administration of injections is thatthere is no official certification or training process. Anyone with aminimal medical related license may inject a patient. These “injectors”may include primary care physicians, dentists, veterinarians, nursepractitioners, nurses, physician's assistants, or aesthetic spaphysicians. However, the qualifications and training requirements forinjectors vary by country, state, and county. For example, in moststates in the United States, the only requirement to inject patientswith neuromodulators and/or fillers is a nursing degree or medicaldegree. This causes major problems with uniformity and expertise inadministering injections. The drawbacks with lack of uniformity intraining and expertise are widespread throughout the medical industry.Doctors and practitioners often are not well trained in administeringinjections for diagnostic, therapeutic, and cosmetic chemicalsubstances. This lack of training often leads to instances of chronicpain, headaches, bruising, swelling, or bleeding in patients.

Current injection training options are classroom based, with hands-ontraining performed on live models. The availability of models islimited. Moreover, even when available, live models are limited in thenumber and type of injections that may be performed on them. The needfor live models is restrictive because injectors are unable to beexposed to a wide and diverse range of situations in which to practice.For example, it may be difficult to find live models with different skintones or densities. This makes the training process less effectivebecause patients often have diverse anatomical features as well asvarying prophylactic, curative, therapeutic, or cosmetic needs. Livemodels are also restrictive because injectors are unable to practiceinjection methods on internal organs due to health considerations. As aresult of these limited training scenarios, individuals seekingtreatments involving injections have a much higher risk of being treatedby an inexperienced injector. This may result in low patientsatisfaction with the results or failed procedures. In many instances,patients have experienced lumpiness from incorrect dermal fillerinjections. Some failed procedures may result in irreversible problemsand permanent damage to a patient's body. For example, patients haveexperienced vision loss, direct injury to the globe of the eye, andbrain infarctions where injectors have incorrectly performed dermalfiller procedures. Other examples of side effects include inflammatorygranuloma, skin necrosis, endophthalmitis, injectable-related vascularcompromise, cellulitis, biofilm, subcutaneous nodules, fibrotic nodules,and other infections.

As a result of the varying qualifications and training requirements forinjectors, there is currently no standard to train, educate, and certifyproviders on the proper and accurate process of various injectiontechniques. Patients seeking injections also have few resources fordetermining the qualifications or experience of a care practitioner.

The present disclosure generally relates to an injection apparatus andtraining system for prophylactic, curative, therapeutic, acupuncture, orcosmetic injection training and certification. The training systemeliminates the need to find live models for hands-on training sessions.The training system provides feedback on trainees and the accuracy ofinjection procedures performed. In an embodiment, feedback is providedin real time. The training system can be used as a measurement on howthe “trainee” is doing prior to receiving actual product by themanufacturing company as a measure of qualification. The training systemreduces the risks associated with inexperienced and uncertified medicalpersonnel performing injection procedures.

The training system can be used to educate, train, and certify medicalpersonnel for injection procedures. It can also be utilized as a testingprogram for certifying medical personnel. The system will enable usersto practice a variety of injections, ranging from on label to off labelproduct injections. In some embodiments, the system may allow users totrain for therapeutic treatments. In other embodiments, the system mayallow users to train for injections into arteries, bone marrow, thespine, the sternum, the pleural space of the chest region, theperitoneal cavity, joint spaces, internal organs, or any other injectionsites. The system may be used for any type of injection, including, butnot limited to those involving prophylactic, curative, therapeutic, orcosmetic treatments in both humans and animals. In other applications,the systems disclosed herein can be used for dental application andtraining for dental procedures.

In one embodiment, there are three main components of the trainingsystem: (1) a training apparatus (also referred to interchangeable as aninjection apparatus throughout the present disclosure) which features ananatomically accurate model of a human or human body part necessary forinjection training, (2) a camera associated with the training apparatus,and (3) a testing tool with light emitting capabilities. In anembodiment, a fourth component of the training system can include aoutput device that can run an application which receives communicationsfrom the training apparatus or camera and generates informationregarding injection parameters based on the communications from theinjection apparatus or camera. In an embodiment, the images captured bythe camera are processed by a processor included either in the injectionapparatus or in the camera before being communicated to the outputdevice. This processing can include, for example, determining anindication of one or more injection parameters. In an embodiment, theanatomical model can include various injection conditions, such as, forexample, layered skin, available in multiple tones and textures to mimica diverse span of age, race, and skin texture. In an embodiment, thelayered skin can be removable and/or replaceable. The apparatus cansimulate any human or animal part, such as, for example, the face, head,brain, neck, back, chest, spine, torso, arms, legs, hands, feet, mouth,or any other body part or portion of the body of interest. In anembodiment, the testing tool can be, for example a syringe or hypodermicneedle. In an embodiment, the injection apparatus is reusable. In anembodiment, the injection apparatus is disposable.

Although the present disclosure specifically describes the use of acamera, it is to be understood that the principles disclosed throughoutthe present disclosure can apply to any light detector or lightdetection device. Moreover, by referring to a camera, the presentdisclosure is not limited to a visible light detection device, rather,any visible or non-visible light detector or detection device can beused as would be understood by a person of skill in the art with anyembodiment disclosed herein.

In one embodiment, the injection apparatus can feature an anatomicallycorrect model of an animal or animal body part. The animal or animalbody part can have a base layer that can be covered in removable skin,animal hair, or scales to replicate the look and feel of a real animal.The skin, animal hair, or scales can be in different colors, coarseness,thickness, density, or stiffness.

In some embodiments, the base layer of the apparatus may be a clearplastic shell simulating a human or animal body part, such as, forexample, a human or animal head. The plastic shell can be covered withlayers of elastomer membranes simulating human or animal muscle or skin.In an embodiment, one or more of these layers can be removable and/orreplaceable. In some embodiments, the top layer of injectable skinconsists of separate layers simulating mammalian skin: the epidermis,dermis, and hypodermis. The layers of injectable muscle and skin may beof uniform density. In other embodiments, the layers of skin may bethicker or thinner to simulate the skin of humans or animals with unevenskin layers or damaged skin. The separate layers of injectable skin mayconsist of elastomers simulating the look and feel of human or animalskin and muscle. The injectable muscle and skin layers may have adifferent transparency. For example, the different layers may be opaque,tinted, or clear.

In one embodiment, the injection apparatus may be used for injections indifferent areas of the human or animal body. For example, the injectionapparatus may simulate the rear torso and buttocks of a human forepidural injections. The injection apparatus can also simulate the backof the neck of an animal for subcutaneous injections. The injectionapparatus may also simulate different organs of the human or body, suchas the heart, brain, or liver. In some embodiments, the injectionapparatus can simulate different bones in human or animal bodies thatrequire injections or extractions. The simulated or synthetic bones cancontain extractable material that simulates bone marrow. The bones canbe separately used as a training apparatus or be placed within ananatomically correct model of a simulated human or animal body part. Forexample, bone marrow extractions can be performed by inserting thetesting tool through skin, muscle, and bone layers of a trainingapparatus. In one embodiment, the injection apparatus may be covered indifferent removable layers of synthetic material for detecting aninjection. The different layers may be opaque, tinted, marked or clear.In some embodiments, the different removable layers of the injectionapparatus may be embedded with sensors that can be pierced by a testingtool. In an embodiment, the apparatus is a human or animal mouth thatcan be used to perform dental or periodontic procedures.

In one embodiment, a testing tool is provided. In an embodiment, thetesting tool is in the form of a hypodermic needle. The hypodermicneedle can be part of a syringe. The hypodermic needle can be of anygauge. The testing tool can be of any size or shape and designed tosimulate the size and shape of an injection tool, such as a syringe,used for any particular type of injection being practiced. In anembodiment, the testing tool has a light source that emits light at thehead of the needle. In an embodiment, a fiber optic is in the needle.For example, the fiber optic can be inserted into or threaded throughthe needle and configured to emit light from a light source through thetip or head of the needle. The light source may be one or more an LEDs,laser diodes, or any other light emitting device or combination ofdevices. In an embodiment, the light source can emit light along aspectrum of visible. In other embodiments, the light source can emitlight of non-visible light, such as infrared light. In some embodiments,the light emitted from the light source is attenuated by each layer ofsimulated skin or muscle. The testing tool can have a barrel. Thetesting tool can also have a plunger associated with the barrel.

The testing tool can be used to practice injections on the injectionapparatus. In an embodiment, the light emitted through the tip or headof the needle of the testing tool is attenuated by the injectionapparatus. The attenuated light is detected by the camera. As the needleportion of the testing tool penetrates through each layer of theinjection apparatus material, different colors, intensities,fluorescence, textures, graph lines, polarization, or other visualeffects of light will be detected by the camera (or any other visible ornon-visible light detector). The resulting visual effects of theattenuated light are detected or viewed by the camera. The visualeffects can represent the differences in location of the injection,depth of the injection, pressure of an injection exerted by the userand/or angle of injection. This information, detected by the camera, canbe communicated to an output device for data collection, testing orcertification purposes. Although the disclosure discloses the use of acamera, the disclosure and claims are not limited to the use of avisible light camera, or typical consumer photography cameras. Rather,the term camera, as used herein, can, in some embodiments, extend to theuse of any light detectors or light detection devices, including, forexample, photodiodes, infrared, polarization, fluorescent or ultravioletlight or thermal imaging cameras or other devices used to detect thepresence or absence of visible or non-visible light.

In some embodiments, a camera is placed within or proximate to theinjection apparatus. The camera can send the information detected to aprocessing unit. The processing unit communicates with an output devicewhich can display the results received from an injection. The outputdevice, also interchangeably referred to herein as an interface device,user device or display device, can include any type of display useful toa user, such as, for example, a tablet, phone, laptop or desktopcomputer, television, projector or any other electronic or paper baseddisplay technology. The processing unit can also collect the informationfor use in data gathering or informatics. Information about theinjection can also be gathered from the testing tool. The output devicemay include lights, graphical displays, audio devices, or user controls.The output device can be an electronic, computer, or mobile device. Thiscan include, for example, a smart phone or tablet. The output device canrun a dedicated application configured to receive wireless communicationdirectly from the camera and/or testing tool and analyze thisinformation for feedback and display to a user. Alternatively, aseparate processor in the injection apparatus and/or testing tool canprocess the information before sending the processed information to theoutput device for display.

In some embodiments, the injection apparatus can be configured to mimiccertain muscle contraction conditions common with a particular type ofinjection. For example, this can include contractions of facialfeatures, such as furrowing of an eyebrow, squinting of the eyes, orpursing of the lips. The removable skin can also include blemishes, suchas scars or wrinkles.

In an embodiment, the layers of material surrounding the injectionapparatus have different pigmentations. For example, in an embodimentwhere the injection apparatus has three layers of pigmentation, thefirst layer may be opaque, the second layer may be tinted, and the thirdlayer may be clear. The pigmentation of the layers selectively altersthe testing tool light to display a different color or intensity oflight as it passes through each layer. This resulting attenuated lightfrom the testing tool is then detected or viewed by the camera enclosedin the injection apparatus. The output device is configured withsoftware to recognize the color, direction, and intensity of lightdetected by the camera. Based on the color, direction, and intensitydetected by the camera, a software program may determine the depth,pressure, or angle of injection. Similarly, markings or otheridentification options can be used to identify the depth, pressure, orangle of injection as described below.

In an embodiment, a system for cosmetic or therapeutic trainingconfigured to aid in training a care provider to provide cosmetic ortherapeutic injections is disclosed. The system includes a testing toolthat has an injection needle head, the testing tool configured to emitlight. The system also includes an apparatus configured to receive aninjection and attenuate the light emitted by the testing tool, theattenuation representative of an injection parameter; and a lightdetector, the light detector positioned to detect the light attenuatedby the apparatus. In an embodiment, the system includes a processorconfigured to receive and process an indication of the detected lightfrom the light detector. In an embodiment, the system includes a displaydevice. In an embodiment, the display device is configured to displaythe indication of the detected light from the light detector. In anembodiment, the indication of the detected light is an image. In anembodiment, the display device is configured to display injectionmeasurement data. In an embodiment, the injection parameter is a depthof the injection. In an embodiment, the injection parameter is an angleof injection. In an embodiment, the injection parameter is pressure. Inan embodiment, the processor is configured to determine an accuracy ofthe injection. In an embodiment, the apparatus includes a plurality ofnesting layers, wherein each layer provides a different attenuation oflight. In an embodiment, each of the plurality of nesting layers arecolored. In an embodiment, at least some of the plurality of nestinglayers are translucent. In an embodiment, the plurality of nestinglayers include a removable skin layer, a muscle layer, and a nervelayer. In an embodiment, the removable skin layer is configured torepresent one or more of different ages, ethnicities, races, textures,or thicknesses of human skin. In an embodiment, the removable skin layeris transparent and the muscle layer is visible through the skin layer.In an embodiment, the removable skin layer simulates cosmeticconditions. In an embodiment, one or more injection sites are positionedat locations on the injection apparatus which correspond to injectionlocations for cosmetic conditions and therapeutic treatment. In anembodiment, the testing tool comprises a light source configured to emitvisible light. In an embodiment, the light detector comprises a camera.

In an embodiment, method of injection training is disclosed. The methodcan include providing a testing tool simulating a syringe and configuredto emit light; providing an injection apparatus, the injection apparatusconfigured to provide a simulation of a testing site and configured toattenuate the light emitted by the testing tool according to a desiredparameter of an injection; providing a light detector configured todetect the attenuated light; using the testing tool to inject theinjection apparatus; and detecting, using the light detector, the lightattenuated by the injection apparatus during the injection. In anembodiment, the method also includes analyzing the detected attenuatedlight from the camera to determine an accuracy of the injection. In anembodiment, the parameter under test is the depth and location of theinjection. In an embodiment, the parameter under test is one or more ofspeed, pressure, angle, depth or location. In an embodiment, theinjection apparatus is configured to attenuate the light by providing aplurality of nesting layers each including a different level of lightattenuation. In an embodiment, each of the plurality of nesting layersis a different color.

In an embodiment, a testing tool is disclosed. The testing tool caninclude a needle; a barrel; and a light source configured to emit lightfrom the needle. In an embodiment, the testing tool also includes aplunger. As will be understood by those of skill in the art, the testingtool described throughout this disclosure and in every embodiment of thedisclosure can be configured to simulate all or various combinations ofparts of a typical syringe or hypodermic needle. For example, this caninclude a needle, a barrel, and a plunger or any combination thereof.Also, any light source or combination of elements described herein canalso be included in the testing tool. In any of the embodimentsdisclosed herein, unneeded or unnecessary parts of the testing tool canbe left off. For example, in some embodiments, a plunger is unnecessaryand left off the device.

In an embodiment, the testing tool can include a sensor configured todetermine a relative position of the plunger with respect to the barrel.In an embodiment, the sensor is potentiometer. In an embodiment, thesensor is housed proximate the barrel. In an embodiment, the sensor ishoused away from the barrel. In an embodiment, the testing tool includesa friction system configured to simulate an injection. In an embodiment,the needle is hollow. In an embodiment, the testing tool includes anoptical fiber configured to transmit the emitted light to the tip of theneedle. In an embodiment, the emitted light is visible light. In anembodiment, the emitted light is one or more of visible light,non-visible light, ultraviolet light, polarized light, infrared light orfluorescent light.

In an embodiment, an injection apparatus configured to simulate at leasta portion of a patient under test is disclosed. The injection apparatusincludes a first structure configured to simulate a portion of a patientunder test; and at least one injection layer configured to simulate aninjection condition, the injection layer configured to attenuate emittedlight from a testing tool such that at least one testing parameter of adesired injection can be determined. In an embodiment, the injectionapparatus includes at least two injection layers, wherein each injectionlayer is configured to attenuate the emitted light. In an embodiment,each of the two or more injection layers attenuates the emitted lightdifferently. In an embodiment, each of the two or more injection layersis tinted with a different color and the emitted light is visible light.In an embodiment, the patient is a human. In an embodiment, the patientis an animal. In an embodiment, the first structure is a head. In anembodiment, the first structure is a back. In an embodiment, the firststructure is a chest.

In an embodiment, a testing tool is disclosed. The testing tool includesa needle; and an optical fiber configured to receive emitted light froma light source through a proximate end of the optical fiber, the opticalfiber further configured to emit light out of a distal end of theoptical fiber, the optical fiber positioned in the needle so that lightis emitted at a head of the needle. In an embodiment, the needle is ahypodermic needle. In an embodiment, the distal end of the optical fiberis located at a tip of the needle. In an embodiment, the emitted lightis visible light. In an embodiment, the emitted light is one or more ofvisible light, non-visible light, ultraviolet light, infrared light orfluorescent light. In an embodiment, the testing tool includes asyringe. In an embodiment, the testing tool includes a barrel andplunger. In an embodiment, the testing tool includes a sensor configuredto determine a relative position of the plunger with respect to thebarrel. In an embodiment, the sensor is potentiometer. In an embodiment,the sensor is housed proximate the barrel. In an embodiment, the sensoris housed away from the barrel. In an embodiment, the testing toolincludes a friction system configured to simulate an injection. In anembodiment, the testing tool includes a friction system configured tosimulate an injection. In an embodiment, the needle is hollow.

In an embodiment, a method of using a testing tool for injectiontraining is disclosed. The method includes providing a testing tool, thetesting tool including a needle; an optical fiber configured to emitlight out of a distal end of the optical fiber, the optical fiberpositioned in the needle so that light is emitted at a head of theneedle; and a light source configured to emit light through a proximateend of the optical fiber. The method also includes using the testingtool to inject an injection apparatus; and detecting the emitted lightafter attenuation by the injection apparatus to determine an injectionparameter. In an embodiment, the needle is a hypodermic needle. In anembodiment, the distal end of the optical fiber is located at a tip ofthe needle. In an embodiment, the emitted light is visible light. In anembodiment, the emitted light is one or more of visible light,non-visible light, ultraviolet light, infrared light or fluorescentlight. In an embodiment, the method further includes providing asyringe. In an embodiment, the method further includes providing abarrel and plunger. In an embodiment, the method further includesproviding a sensor configured to determine a relative position of theplunger with respect to the barrel. In an embodiment, the sensor ispotentiometer. In an embodiment, the sensor is housed proximate thebarrel. In an embodiment, the sensor is housed away from the barrel. Inan embodiment, the method further includes providing a friction systemconfigured to simulate an injection. In an embodiment, the methodfurther includes providing a friction system configured to simulate aninjection. In an embodiment, the needle is hollow. In an embodiment, themethod further includes storing the injection parameter in an electronicstorage device. In an embodiment, the method further includes compilinga plurality of injection parameters from an injector and determining anaccuracy rating of injection. In an embodiment, the method furtherincludes publically publishing the accuracy rating.

In an embodiment, a method of rating an injector is disclosed. Themethod includes using an injection apparatus to detect injectionparameters about an injection by an injector using a testing tool; anddetermining a rating of the injector from the injection parameters. Inan embodiment, the injector is a primary care physician, dentist,veterinarian, nurse practitioner, nurse, physician's assistant,aesthetic spa physician, plastic surgeon, facial plastic surgeon,oculoplastic surgeon, or dermatologist. In an embodiment, the rating isan accuracy of injections. In an embodiment, the rating is an experienceof the injector. In an embodiment, the rating indicates a quality of theinjector. In an embodiment, the rating is publically published. In anembodiment, the rating is one or more of education, years of experience,performance results with the injection apparatus, or patient reviews.

In a further innovative embodiment, an anatomically shaped injectiontraining apparatus is provided. The apparatus includes an at leastpartially hollow base configured to provide structural support. Theapparatus also includes a clear layer of elastomer coating at leastpartially covering the base layer. The apparatus further includes anopaque layer at least partially covering the clear layer. The base,clear layer, and opaque layer form an anatomical shape. The apparatusalso includes a three-dimensional (3D) tracking system positioned insidethe base and configured to determine a location of a needle insertedinto the clear layer of elastomer. In some implementations of theapparatus, a light is emitted from the needle tip.

The 3D tracking system may be configured to track multiple locations ofthe needle overtime. The 3D tracking system may comprise one or more ofa camera, a stereoscopic pair of cameras, or an array of light sensors.The 3D tracking system may be configured to determine the location ofthe needle based on a measurement of one or more characteristics of anemission from the needle. The emission from the needle may includelight, and the characteristics include intensity, angle, dispersion,brightness, color, and duration of the light. In some implementations,the emission from the needle may include sound, and the characteristicsmay include intensity, angle, duration, frequency, and amplitude.

It may be desirable, in some implementations of the apparatus, totransmit the location of the needle with respect to an injection site onthe apparatus for display via an electronic display. In suchimplementations, the electronic display may be configured to display theindication of the detected light from the light detector. The indicationof the detected light may be provided as one or more of an image, ananimated depiction of the needle passing through the injection site. Ananimated depiction may be a stored video of the needle passing throughthe injection site or be generated based on a stored plurality oflocations for the needle. The animated depiction can be generated basedon a display point of view, the display point of view identifying avirtual location in space from which to view the animated depiction.Some display devices may be configured to alternatively or additionallydisplay injection measurement data.

The opaque layer may be, in some implementations, configured torepresent one or more of different ages, ethnicities, races, textures,or thicknesses of human skin.

In a further innovative aspect, a method of manufacturing ananatomically shaped injection training apparatus is provided. The methodincludes forming an at least partially hollow based configured toprovide structural support for a target injection test area. The methodincludes coating at least a portion of the base with a clear layer ofelastomer. The method further includes coating at least a portion of theclear layer with an opaque layer. The base, clear layer, and opaquelayer form an anatomical shape. The anatomical shape may include a humanskull. The method also includes affixing a three-dimensional (3D)tracking system within a hollowed portion of the base, wherein thethree-dimensional tracking system provides a field of view of the clearlayer covering the target injection test area.

Affixing the 3D tracking system may include affixing a 3D camera withinthe hollowed portion of the base. Affixing the 3D tracking system mayinclude affixing a first camera and a second camera within the hollowedportion of the base, wherein a center point of said first camera isaligned with a center point of said second camera, and the first cameraand the second camera are configured as a stereoscopic camera pair.

The method may also include coupling the 3D tracking system with alocation processor configured to provide location information for alight source inserted into the clear layer. The location information mayidentify a three-dimensional location of the light source relative tothe injection training apparatus.

In yet another innovative aspect, a method of three-dimensional (3D)injection training is provided. The method includes calibrating at leastone of a light source and a three-dimensional tracking system. Themethod also includes detecting, by the three-dimensional trackingsystem, a characteristic of light emitted from the light source for aninjection. The method further includes generating three-dimensionallocation information of the light source based on the detectedcharacteristics and the calibrating.

Calibrating may include, in some implementations, obtaining calibrationinformation from a memory. In some implementations, calibrating includesreceiving, at the three-dimensional tracking system, light from thelight source from a predetermined location, generating calibrationinformation, and storing the calibration information in a memory.

The method may include detecting by receiving a plurality ofmeasurements from an array of light sensors included in thethree-dimensional tracking system. The detecting may be based on whichsensors in the array of sensors received measurable light. Thecharacteristic of the light emitted which is detected may includeintensity, angle, dispersion, brightness, color, and duration of thelight.

The method may also include obtaining a three-dimensional model of asite for the injection and generating an injection training result basedon the location information for the light and the three-dimensionalmodel of the site. Injection training results may include an animateddepiction of the injection at the site. Some implementations of themethod may include receiving a display point of view, the display pointof view identifying a virtual location in space from which to view theanimated depiction. In such implementations, generating the injectiontraining result may be further based on the display point of view. Themethod may also include detecting a plurality of locations for theinjection over time. In such implementations, generating the injectiontraining result includes generating a trajectory path for the injection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an embodiment of the injection apparatus, testing tooland output device.

FIG. 2A depicts an embodiment of the testing tool.

FIG. 2B depicts an embodiment of the testing tool with a linearpotentiometer fixed to the testing tool.

FIG. 2C depicts an embodiment of the testing tool with a linearpotentiometer remotely connected to the testing tool.

FIG. 2D depicts a cross section of the multi-lumen sheath.

FIG. 3 depicts a schematic diagram of a testing tool for injectiontraining.

FIG. 4A depicts the side view of one embodiment of the injectionapparatus with a surrounding testing layer of simulated skin and musclecovering a portion of the injection apparatus.

FIG. 4B depicts the side view of one embodiment of the injectionapparatus with a surrounding testing layer of simulated skin and musclecovering the entire injection apparatus.

FIG. 5 depicts the side view of one embodiment of the injectionapparatus with a grid displayed with injection sites.

FIG. 6 a schematic diagram of the camera system.

FIG. 7 illustrates a view of an embodiment of the injection apparatuswith a removable band.

FIG. 8 depicts an exploded perspective view of an embodiment of aremovable band.

FIG. 9 depicts a cross sectional view of simulated human skin and musclelayers at an injection site.

FIG. 10 illustrates the progression of a testing tool being injectedinto an injection apparatus.

FIG. 11 illustrates a front view of an injection apparatus for cosmetictraining with cosmetic conditions labeled to corresponding injectionsites on a muscle layer.

FIG. 12 illustrates an injection apparatus and output display depictingthe corresponding image of the injection apparatus.

FIG. 13 is a flowchart illustrating an embodiment of a method forutilizing an injection apparatus.

FIG. 14 is a flowchart illustrating an embodiment of a method forutilizing an injection apparatus in a simulated injection test.

FIG. 15 illustrates a user interface for injection training through aninjection apparatus.

FIG. 16 illustrates an injection apparatus for prophylactic, curative,therapeutic, or cosmetic training with a skin layer displayed.

FIG. 17 illustrates an injection apparatus for therapeuticneuromodulation training with the muscle layer displayed.

FIG. 18 illustrates an injection apparatus for injection training withinjection sites displayed on a muscle layer.

FIG. 19 illustrates an injection apparatus for injection training with amuscle layer displayed and labeled.

FIG. 20 illustrates an injection apparatus for injection training with amuscle layer display and labeled with cosmetic flaws.

FIG. 21 illustrates the back view of an injection apparatus fortherapeutic neuromodulation training with a human face, head, neck andupper torso.

FIG. 22A illustrates the display of a mapped dermal filler injection andone embodiment of scoring the injection.

FIG. 22B illustrates the expanded view of a mapped dermal fillerinjection.

FIG. 23 depicts a resulting output of an injection test on an outputdevice.

FIG. 24 illustrates an injection apparatus for injection or open brainsurgery training with a human brain displayed and labeled.

FIG. 25 illustrates an injection apparatus for injection or eye surgerytraining with a human eye displayed.

FIG. 26 illustrates an injection apparatus for injection or spinalsurgery training with a human spine displayed.

FIG. 27 illustrates an injection apparatus for injection training withthe anatomy of a dog displayed.

FIG. 28 illustrates an injection apparatus for injection training withthe anatomy of a rat displayed.

FIG. 29 illustrates a further embodiment of the injection apparatus,testing tool and output device.

FIGS. 30A and 30B illustrate two views of a trajectory for an injection.

FIG. 31 illustrates an example of a 3D injection detection sensor.

FIG. 32 illustrates another example of a 3D injection detection sensor.

FIG. 33 depicts a side view of one embodiment of the injection apparatusincluding a 3D injection detection sensor.

FIG. 34 shows a process flow diagram of a method of manufacturing ananatomically shaped injection apparatus including a 3D tracker.

FIG. 35 shows a process flow diagram for a method of three-dimensional(3D) injection training.

DETAILED DESCRIPTION

Embodiments will now be described with reference to the accompanyingfigures, wherein like numerals refer to like elements throughout. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive manner, simply because itis being utilized in conjunction with a detailed description of certainspecific embodiments of the disclosure. Furthermore, embodiments of thedisclosure may include several novel features, no single one of which issolely responsible for its desirable attributes or which is essential topracticing the present disclosure.

FIG. 1 depicts the use of an injection apparatus 100 used for injectiontraining. The injection apparatus 100 can be used for any type ofinjection training involved with administering diagnostic andtherapeutic chemical substances. For example, injection training can beprovided for epidural techniques and intracardiac injections. In oneembodiment, the injection apparatus 100 can anatomically model the face,neck, and head of a human or animal. Although not shown in theaccompanying drawings, the injection apparatus can model other injectionsites including the chest, arms, mouth, back, buttocks, etc. Theinjection apparatus 100 may also represent any body part of a human oranimal, including internal organs. In some embodiments, the injectionapparatus 100 may consist of a simulated skull and layers of muscle andskin.

A testing tool 110 is also illustrated which can be used with theinjection apparatus 100 and in conjunction with a camera 120 locatedwithin the injection apparatus 100. The testing tool 110 may simulateany type of equipment used in connection with an injection or minimallyinvasive procedure, such as a needle, catheter or cannula. As describedin further detail below, the camera 120 can capture visual indicationsof the user's injection using the testing tool 110. The visualindications provide an operator or user with information regarding thelocation, depth, pressure, or angle of the injection. In an embodiment,the testing tool 110 contains a light source that emits light throughthe needle portion of the testing tool which is used to aid in obtainingthe visual indications detectable by a camera 120. The light source canemit visible light. In an embodiment, a gradient of white light isemitted through the needle portion of the testing tool. Other colors ofvisible light can also be used, such as green, blue, red, yellow or anycombination of those colors. In an alternative embodiment, the lightsource may emit light along a spectrum of visible or non-visible light,such as fluorescent or ultraviolet light. In some embodiments, the lightemitted from the light source is attenuated differently depending onwhich layer of simulated skin or muscle of the injection apparatus 100is penetrated. Different colors, directions, graph lines, visualpatterns, polarization, fluorescence, or intensities of light can becaptured by the camera 120 as the testing tool 110 is injected throughthe different layers of material surrounding the injection apparatus100. The resulting light detected by the camera 120 can be used todetermine the location of the injection, the pressure exerted by theuser, the angle of injection, or the depth of the injection. Thisinformation can be detected, for example by a camera 120, andcommunicated to a user interface device 140 for testing or certificationpurposes.

The camera 120 within the simulated skull of the injection apparatuscaptures the attenuated light of an injection through video recordingand/or photographic images. The camera 120 can include a processor andcan communicate the camera output to a user interface device 140. Theinformation gathered from the camera 120 and testing tool 110 may becommunicated to a user interface 140 for data collection, testing orcertification purposes. The camera output can be raw or processed videoor images obtained from the camera 120. The camera processor can includesoftware configured to interpret the visual indications for testingpurposes or can merely pass images to the user interface device 140 forfurther processing. In an embodiment, the user interface device 140 canalso communicate instructions to the camera 120 and/or testing tool 110.

FIG. 2 depicts an embodiment of the testing tool 110. In one embodiment,the testing tool 110 includes a needle 212, plunger 209, and barrel 210.The testing tool 110 may be activated by pressing the switch button 200which moves switch contacts 201 and connects the battery 203. Thebattery 203 and switch button 200 are within the housing 202 of thetesting tool 110. The battery 203 powers the LED 204 to emit a lightthrough a lens 205. The emitted light then travels through an opticalfiber 207 that captures the focused light. Alternatively, the light cantravel through a hollow needle, without the use of optical fibers. Theoptical fiber 207 is held within the plunger 209, barrel 210, and needle212 of the testing tool 110 through a slide slot 208. Alternatively, thefiber optic and other components are all fully incorporated into thetesting tool to create a standalone device. The light emitted from theLED 204 travels through the optical fiber 207 and is emitted at the tipof the needle 212 as a focused light 213. In one embodiment, the needle212 of the testing tool 110 may be hollow and allow light to enterwithout a focused tip. The LED 204 may emit light of different spectrumsthrough a lens 205. In some embodiments, the light emitted from the LED204 is attenuated once it penetrates each layer of simulated skin ormuscle. Once the needle portion 212 of the testing tool 110 penetratesthrough each layer of tinted material, different colors or intensitiesof light can be detected by the camera 120. In some embodiments, afriction o-ring 211 allows the plunger 209 to be pushed downward andcauses the needle 212 to go forward for an injection.

In some embodiments, the light viewed by the camera 120 from the needle212 can change from a round to oval shape. This can occur when theneedle moves out of alignment with the camera 120. The length and widthof the oval viewed by the camera 120 can indicate the angle of theinjection while the direction of the oval along its longer axis canindicate the direction of the injection.

In some embodiments, fluid can be stored within the testing tool 110 andinjected into the injection apparatus 100. The fluid injected cansimulate the consistency of the injection substance that would beinjected for a real treatment. Once the injection apparatus 100 receivesthe injection, a camera 120 captures the location, speed, pressure, andangle of the injection. The camera 120 sends this information in videoor photographic form to the processor 604 which analyzes the detailedinformation and determines desired injection parameters. In someembodiments, the data associated with the injection can be determined bythe testing tool 110 sending information wirelessly to the processor604. For example, the testing tool may detect the friction experiencedby the friction o-ring 211 to send to the processor 604 informationabout the speed and pressure of an injection. In one embodiment, anaccelerometer can be attached to the testing tool 110 to provideinformation on an angle of injection. Another process for conveyinginformation to the processor 604 includes alternating frequencies orpatterns of light emitted by the LED. Alternatively, the informationfrom the camera 120 and testing tool 110 can be sent directly to theoutput device 140 for processing.

In one embodiment, the plunger 209 of the testing tool 110 may be ableto detect the angle, speed, friction, and depth of an injection. Thiscan be accomplished with a wired or wireless electrical signal beingtransmitted from a sensor placed in the testing tool 100. In someembodiments, a cable can be placed parallel to the light fiber that canread the injection parameters, such as the pressure, speed, oracceleration of the injection. For example, the electrical signaltransmitted from the sensor can detect 0-5 volts of electricity, whichcan represent the amount of pressure being exerted by the user whenutilizing the testing tool 110. In other embodiments, the electricalsignal may emit a certain frequency that represents the pressureexerted. For example, a frequency of 100 Hz can represent low pressurewhile a frequency of 1,000 Hz can represent high pressure exerted by theuser. In an embodiment, the LED can be modulated at a modulation ratecorresponding to an angle, speed, friction or depth of an injection.This modulated light can be detected by the camera and used to determinethe desired injection parameters without the need for a separate datacommunication path between the testing tool and the rest of the system.In some embodiments, a wireless transmitter can be placed in the testingtool that communicates directly to the user interface device 140 anddisplays the parameters of the injection.

In some embodiments, the testing tool 110 can inject a fluorescent fluidinto the injection apparatus 100. The layers of simulated muscle andskin may be configured to have a reservoir that accepts these fluidinjections. The fluorescent fluid may be visible through transparent,opaque, or lightly pigmented material in the simulated skin and musclelayers. In one embodiment, a UV lamp may be placed within the injectionapparatus 100 in order for a user to clearly see the injection andinjected fluid going into the injection apparatus 100.

In some embodiments, the testing tool 110 may also be powered with aplug in cable. The testing tool 110 can send information over a wirelessnetwork or portable computer to process information about an injection.The signals may send information related to the 3D location, depth,intensity, or pressure exerted by the user when practicing theinjection.

FIG. 2B depicts an embodiment of the testing tool with a positiontransducer, such as, for example, a linear potentiometer fixed to thetesting tool. The linear potentiometer can be used to track thedepression of the plunger 209 relative to the barrel 210. Thisinformation can then be used by the system to determine a volume ofinjection. This information, in connection with the location and depthinformation obtained by the injection apparatus can be used to determinefluid volume distribution information about the injection.

In some embodiments, the transducer or potentiometer can be connected toa slider 216. The linear potentiometer 214 measures the position of theplunger 209 of the testing tool relative to the barrel 210. In someembodiments, the linear potentiometer 214 may be fixed to the plunger209 of the testing tool. A slider 216 may be attached through a slot 225in the barrel 210 and mated with a pocket within the plunger 209. Theslider 216 moves with the plunger 209 to allow the transducer to outputthe position of the plunger 209 through an output pin 215. Thetransducer then electronically communicates through a connection with aprocessor 604, which calculates the simulated volume and distribution ofthe injection. This calculation may be completed by using the parametersof the plunger 209 displacement and the diameter of the barrel 210.

In some embodiments, the testing tool determines the pressure applied bythe injector. This can be accomplished by measuring the force applied tothe plunger 209 through a thin film force sensor 217 on the plunger 209flange. Electrical connections to the force sensor and linearpotentiometer may be placed along with the optical fiber 207 in amulti-lumen sheath. The force sensor 217 electrically communicates witha processor 604 (FIG. 6) and send the parameters associated with theapplied force to the plunger 209. The injector can be used for variousprocedures with various needle sizes, medication viscosities, and skinor muscle properties.

FIG. 2C depicts an embodiment of the testing tool with a linearpotentiometer 214 remotely connected to the testing tool. The motion ofthe plunger 209 is measured using a pull wire 219 that is connected tothe plunger 209 and to the slider 216 of a remote transducer. The pullwire 219 may be routed along a multi lumen sheath 218 that carries theoptical fiber 207.

In an embodiment, the remote transducer is used in conjunction with aforce application system to simulate the viscosity encountered during aninjection. In an embodiment, a needle drag can be designed to simulate areal injection. The needle drag can be determined based on theelasticity of the injection apparatus layers (for example, as measuredin durometers), the coefficient of friction between the plunger and thebarrel and the needle diameter and length. FIG. 2C illustrates a forceapplication system including a tension spring 222, steel tensile strip221, steel friction block 223, and a controllable friction device, suchas an electromagnetic brake. The electromagnetic brake is activated whencurrent from a power source is applied to a coil 220. Once current isremoved from the coil 220, the electromagnetic brake returns to itsresting state. These elements of the testing tool provide the resistancenecessary for a simulated injection. The electromagnetic brake can becontrolled by the processor 604 to simulate the feel and resistance ofan actual injection. Alternatively, the parameters of the brake forceapplied can be preset. A fixation post 224 may be used to lock thebarrel 210 and multi lumen sheath 218 together. In some embodiments, theelectromagnetic brake may be adjusted to simulate the resistance ofskin, tissue, or muscle that the needle 212 would be penetrating. Forexample, an injector performing a lumbar nerve root sleeve injectionwould be able to feel the resistance of a fluid containingcorticosteroid and long-acting local anesthetic. The electromagneticbrake also provides the resistance corresponding to a hypotheticalpatient's skin, tissue, or muscle. The injector applies thecorresponding amount of force necessary to correctly perform theinjection.

FIG. 2D depicts a cross section of the multi-lumen sheath 218. The multilumen sheath 218 holds the optical fiber 207 and the pull wire 219. Thepull wire 219 may be attached to the plunger 209 and moves the slider216. As the plunger 209 moves, the pull wire may move through the multilumen sheath 218.

FIG. 3 depicts a schematic diagram of a testing tool for injectiontraining. In one embodiment, the testing tool 110 has a needle 212,plunger 209, and barrel 210. The testing tool 110 can have a light fiberand/or light emitting diode (LED) 320 as a light source. The focus ofthe light source may be on the end of the fiber inside the needleportion of the testing tool 110. The testing tool 110 is activated by aswitch button 300 which connects the battery and activates the LED 320.In some embodiments, the testing tool 110 is a portable batteryoperated, fully functional, standalone device. The battery 310 powersthe LED 320 and activates the LED 320 once the switch button is turnedto the on position. The LED 320 emits light through a fiber optic cable330 so that light 340 shines through the needle portion of the testingtool 110. In some embodiments, the testing tool 110 may be connectedthrough a cable to a processor 604 which is able to communicate with thetesting tool 110 in order to receive information on testing parametersand provide programming instructions to the testing tool 110. In otherembodiments, the testing tool 110 may wirelessly communicate with theprocessor 604.

FIG. 4A depicts a side view of one embodiment of the injection apparatus100 with a surrounding removable layer divided into three separatesimulated human skin and muscle layers 410, 420, 430. In someembodiments, the skin layers may be separated to represent theepidermis, dermis, and hypodermis. The layers of skin and muscle may beof uniform or different densities. In other embodiments, the layers ofskin and muscle may be thicker or thinner to simulate the skin ofpatients with uneven skin, muscle layers, or damaged skin. In someembodiments, each separate layer may be of a different density or color.For example, in FIG. 4, the first layer 410 may represent the epidermisas opaque. The second layer 420 may represent the dermis and as tinted.The third layer 430 may represent the muscle and as clear. More or fewerlayers of simulated skin and muscle can also be used depending on thedesired injection and the level of detail required.

In some embodiments, each separate layer of skin or muscle 410, 420, 430may be of a different transparency, density or color. In someembodiments, the different intensity or colors can be viewed by thecamera after the testing tool 110 is inserted into the simulated skin ormuscle. This can allow a camera 120 to send information to a processor604 related to the location, pressure, angle, or depth of an injection.In other embodiments, the injectable muscle and skin layers may be ofuniform density, consistency, or color. In some embodiments, theinjectable muscle and skin layers 410, 420, 430 may be made of anelastomer. In an embodiment, the elastomer may simulate the elasticityof human skin and range from 5-35 on the durometer “A” scale. Thesimulated skin and muscle layers 410, 420, 430 may also consist ofdifferent angled fibers that deflect light emitted from a testing toolin different directions to allow for location, depth, angle and pressureanalysis based on the optical properties observed. In an embodiment, thefibers can be a pattern printed on each skin or muscle layer 410, 420,430 that selectively block light viewed by the camera. Depending on theangle of the fibers within each layer of the skin and muscle layers 410,420, 430, the light emitted from a testing tool may be deflected at thatangle. For example, the first layer 410 may have threaded angled fibersdirected at a 45 degree angle. The second layer 420 may have threadedangled fibers directed at a 55 degree angle. The third layer 430 mayhave threaded angled fibers directed at a 65 degree angle. Depending onwhich layer an injector has penetrated, the light emitted from a testingtool 110 may be deflected in a different direction. If the injector haspenetrated the second layer 420, the light should be deflected at a 55degree angle. The deflection of the light emitted from the testing tool110 is captured by a camera 120 and sent to a processor 604. Theprocessor 604 analyzes the intensity, deflection, and clarity of thelight emitted from the testing tool 110 to generate results about theinjection.

In some embodiments, the layers of skin or muscle 410, 420, 430 may bedyed with carbon black particles or similar light-obscuring agents. Thedensity of the carbon black particles can be adjusted to substantiallyblock emitted light from reaching the camera through all layers. As theneedle portion of the testing tool 110 travels through each layer, morelight is viewed by the camera. The carbon black particles obscure lightso that an injection into each layer may represent a different intensityof light. In some embodiments, this will allow a camera 120 placedwithin the injection apparatus 100 to detect the layer of skin or muscle410, 420, 430 which is being penetrated by the light source. In oneembodiment, the different layers of skin or muscle may be dyed withtranslucent color. These translucent layers will attenuate the lightemitted from a testing tool in different ways. The degree and color ofattenuation of the light after it has traveled through the simulatedmuscle and skin layers can then be detected by the camera and used toanalyze the injection.

In an embodiment, the system includes an injection apparatus 100 forinjection procedures on different parts of the human body. In anembodiment, there are at least three nesting layers of the apparatus:the skeletal structure layer, muscle layer, and top layer of simulatedskin. A nerve layer can also be present within the muscle layer. Thisallows trainees to visualize and study the layers of muscle and nervesunderneath the skin layer to become familiar with human facial anatomy.Veins or arteries can also be included and embedded within the musclelayer. The veins or arteries may be of a different color or density thanthe muscle and skin layers. The injectable muscle and skin layers 410,420, 430 anatomically match that of the human body. In some embodiments,the injection apparatus 100 may simulate the internal organs or otherbody parts of a human or animal. In some embodiments, injectable muscleand skin layers 410, 420, 430, may be color coded so that a trainee maybe able to identify the different sections of the human body or musclesassociated with each simulated condition.

The depicted layer on the injection apparatus 100 in FIG. 4A simulateshuman skin and muscle and has the same feel, permeability, andappearance as human skin. The skin and muscle layers may be removable,reusable, and replaceable to simulate a variety of patients havingdifferent injection conditions. For example, the skin may vary by theage, ethnicity, race, texture, or thickness of different test patients.In some embodiments, the skin may simulate certain cosmetic conditions.For example, the skin may have wrinkles, scars, hyper-pigmentation,lacerations, or other blemishes typically treated by injections. Thevarious embodiments of skin types allow the trainee to gain a widevariety of experience dealing with different skin types. The musclelayers may consist of thicker or thinner layers to represent differentdensities in muscle tone. In some embodiments, the different density orcolor of the skin or muscle may allow a testing tool and camera todetect the depth and location of an injection.

In some embodiments, the injection apparatus 100 is configured torepresent human facial features, such as those features associated withsmiling or frowning, as would be encountered during certain cosmetic ortherapeutic injections. In some embodiments, the apparatus can modelvarious cosmetic conditions or damaged areas of the human body. Forexample, these cosmetic conditions may include glabellar frown lines,horizontal forehead lines, temporal brow lifts, crow's feet (lateralcanthal lines), lower eyelids, nasalis bunny lines, vertical lip lines,gummy smiles, nasolabial folds (NLFs), marionette lines, pre-jowlsulcus, labiomental crease, and midface, facial lipoatrophy, lipaugmentation, mouth frowns (depressor anguli oris), apple dumpling chin,horizontal neck lines, vertical platysmal bands, acne blemishes,accident scars, or asymmetry. In some embodiments, the skin can bemanipulated to mimic actual facial movement, such as furrowing of thebrow, squinting of the eyes, and pursing of the lips. Users of theinjection apparatus may be able to pinch the skin, stretch the skin, orgrab a portion of the muscle in order to simulate a real injection. Theinjection apparatus 100 may be programmed to display various cosmeticconditions through a user interface device 140. There may also bebuttons available on the injection apparatus 100 for programmingcosmetic conditions. In some embodiments, the skin layer may bemanufactured with pre-determined cosmetic conditions.

In one embodiment, programs for individual injection sites may be soldseparately or in a package. The user interface device 140 may be updatedwith various injection tests for different parts of the human or animalbody. For example, an injection test can be purchased for Botox®injections. The injection sites for parts of the human face could bedownloaded onto the user interface device 140 and unlocked by a user.For example, the targeted injection sites for toxin cosmetic injectionsfor a human face may include the frontalis (forehead lines), glabellarcomplex (procerus and corrugators) frown lines, orbicularisoculi-lateral canthal area, crow's feet lines, nasalis-bunny lines,orbicularis oris-vertical lip lines, depressor anguli oris, mentalis,masseter, platysma, depressor septi nasi, levator labii superiorisalaeque nasi, gland hypertrophy, or labial artery. The program cancommunicate with the processor 604 to control the movement of the camera120 to record or measure the specific injection sites for injectiontesting. The program can also communicate with the processor 604 tochange the pigmentation or color of the skin layers 410, 420, 430 of theinjection apparatus 100. In some embodiments, the program can be set tosimulate a specific type of injection scenario. For example, a user canset the user interface device 140 to simulate crow's feet on theinjection apparatus 100. The skin layers 410, 420, 430 would bemechanically moved to simulate the wrinkles at the edge of the injectionapparatus 100 to form crow's feet. Once the user correctly injects theinjection apparatus 100 at the injection site for crow's feet, theinjection apparatus 100 would mechanically smooth out the wrinkles fromthe crow's feet.

In one embodiment, the program can inform the user of the type oftreatment performed on the injection apparatus 100 through the userinterface device 140. For example, the user interface device 140 mayeducate the user on the type of treatment, such as whether it istherapeutic, sub-therapeutic, or super-therapeutic.

The injection apparatus 100 may also be used for therapeutic treatmenttraining. These treatments may include those related to blepharospasm,strabismus, or chronic migraines, and others. For example, Botox®injections can be practiced to induce localized, partial paralysis onthe apparatus for treatment of blepharospasm. In some embodiments, theinjection apparatus may be manipulated to display the different physicalfeatures associated with conditions requiring therapeutic treatment. Forexample, the injection apparatus 100 may display a squinted eye or becross-eyed when it is programmed as a patient with strabismus. Upontherapeutic treatment by a trainee, the injection apparatus 100mechanically readjusts to fix the condition.

In some embodiments, the base layer 400 allows the injection apparatus100 to keep its structure and holds the components of the injectablemuscle and skin layer in place. The base layer 400 may be mechanical andmoveable in response to an injection from the testing tool 110. The baselayer 400 may be mapped with a grid of target zones. For example, theinside or outside of the base layer 400 may have imprinted lines thatrepresent zones of injection. The grid of target zones may correspond toan image on a user interface device 140 that is able to show theaccuracy of an injection. The grid can show the face from the inside ofthe camera and what the muscles look like. This can occur, for example,in a training mode. In some embodiments the top skin layer 410 may havevisual targets which display the location for injection corresponding toa cosmetic condition or therapeutic treatment. These visual targets maybe color coded so that a user may be different injection zones thatshould be targeted for administering different injections.

In some embodiments, the base layer 400 of the apparatus may be a clearplastic shell. The plastic shell layer may be covered with removablelayers of elastomer membranes simulating human muscle or skin. Theplastic shell may simulate the look of any human body part, includingany internal organs. In some embodiments, the injection apparatus 100simulates an entire human or animal body part with or without removablelayers of elastomer membranes simulating human skin or muscles.

In an embodiment, the injection apparatus may have a camera 120 attachedto a pivotable stand 460 and placed within the injection apparatus 100.The pivotable stand 460 may be attached to a removable base 470 thatallows a user to physically change the direction of the pivotable stand460. In some embodiments, the pivotable stand 460 may be mechanicallymovable upon detection of a signal received through a processor 604. Theprocessor 604 may receive a signal to change the location of thepivotable stand 460 through a output device 140.

In some embodiments, the camera 120 may be positioned so it may swinginto different positions in response to a shift gate. This allows a userto move the camera 120 to focus on different target zones without havingto manually move the camera within the injection apparatus 100. Thecamera 120 may include an angular grid sensing filter that can detectits position and rotate itself according to a displayed grid within theinjection apparatus 100. In an embodiment, the camera 120 is set tofocus on either color or line orientations within the injectionapparatus 100. The camera 120 may read a user's injection based on theinformation received from the light emitted from the testing tool 110 inconjunction with the location determined by a grid embedded in the baselayer 400 of the injection apparatus 100.

In some embodiments the camera 120 may have a broad or focused range450. For example, a broad range camera may be used when there is nospecific target area that is being focused on for testing orcertification purposes. A focused range camera can be positioned to aimat a zone for injection. In some embodiments, the camera 120 isconfigured to communicate with a user interface device 140 to displaythe results of an injection. In an embodiment, the results of theinjection may be determined by the intensity and color viewed by thecamera 120 after the testing tool 110 has been injected into thedifferent layers of skin or muscle. The range 450 of the camera 120 maybe manually adjusted by setting the camera to encompass a smaller orbigger range. The range 450 of the camera 120 may also be adjusted byinputting a grid location into the output device 140 and communicated tothe camera 120. The camera 120 then adjusts its targeted location.

The camera 120 can output video to a user interface device 140 through awired or wireless connection. In an embodiment, the output device 140 isequipped with software to read and analyze the results obtained from thevideo. In an embodiment, the software is able to analyze the results andgenerate a score or evaluation of the user's injection. The software canalso report and capture data on the trainee's experience. The softwaremay also play back the user's injection and display errors or providefeedback acceptable injections. In an embodiment, the software includesa biometric sensor to identify each trainee.

FIG. 4B depicts a side view of one embodiment of the injection apparatus100 with a surrounding removable layer including at least threesimulated human skin and muscle layers 410, 420, 430. The surroundingremovable layer may cover one section of the injection apparatus 100 orthe entire injection apparatus 100, for example, as illustrated in FIG.4B. In some embodiments, the human skin and muscle layers 410, 420, 430can be removed separately. As discussed above, more or fewer skin andmuscle layers can be used and the present disclosure is not intended tobe limited to three layers.

In an embodiment, the injector or administrator of injection trainingmay choose to focus on a specific area of the injection apparatus andonly have the removable layer surrounding that area. The injector maythen observe the injection apparatus 100 to see how an injectionpenetrates through the different layers of skin, muscle, and nerves.This embodiment may be used, for example, for novice injectors whorequire visual guidance for the depth of their injections.

FIG. 5 depicts the side view of an embodiment of the injection apparatus100 with a grid displayed with injection sites. The grid lines 500 areused by a user or a camera 120 to determine the location of an injectionsite 520. The grid lines 500 may represent locations on an x-y plane ora three dimensional x-y-z axis so that a camera 120 may easily transferlocation data to a processor 604. The grid lines 500 may be placed in anarrangement where each created section may represent an injection site520. The sections may also be targeted areas that are used by the camera120 to indicate where to focus for a particular injection. The gridlines 500 may be placed in different directions long the injectionapparatus 100 or angled to accommodate any grooves or bumps on theinjection apparatus 100.

In some embodiments, the injection apparatus 100 may have sensorsembedded within the different human skin and muscle layers 410, 420,430. The sensors may be located on an injection site 520, multipleinjection sites 520, or continuously throughout the entire human skinand muscle layers 410, 420, 430. Once an area has been treated by aninjection, the sensor may communicate with the testing tool 110 or theinjection apparatus 100 to provide the information associated with theinjection. For example, the sensor would be able to test reads thetreatment from the sensors. The pressure applied to the area ofinjection may be detected by the training tool and the parameters of theinjection may capture the depth, pressure, and angle of a user'sinjection. The parameters may then be compared to a pre-determinedtreatment and provided to a user interface device 140, which displaysthe testing results.

In some embodiments, the injection apparatus 100 may have inflatablepads embedded within the different human skin and muscle layers 410,420, 430. The inflating and deflating of the pads may be initiated by anattached sensor detecting the penetration of an injection. Theinflatable pads may be located on the injection site 520. The inflatablepad may independently inflate or deflate proportionally to the location,depth, pressure, and angle of a user's injection. The inflation andresulting size of the pads may differ at various injection sites 520,depending on the natural human reaction to an injection in that area.Once a user has completed an administered test, the inflatable pad maydeflate and return the human skin and muscle layers to their originalcondition. The inflation pads allow the asymmetries of an injection tobe observed and addressed by the injector. In an embodiment, the testingtool injects air into the inflatable pads, skin and/or muscle layers sothat a user can observe how the injection has affected the apparatus.This allows the trainee to see in real time the effect of the injection.For example, the effect can be watching the apparatus “age”. In anembodiment, the trainee can also deflate the fat pads. This allows atrainee to practice determining how much injection is required for agiven patient.

In some embodiments, the injection apparatus 100 can be configured toturn on the measurement and/or analysis of different injection sites520. A software program communicating through the user interface device140 can selectively enable certain procedures, for example, throughseparate software purchases or upgrades related to particular injectionsites 520. For example, the injection sites 520 for Botox® procedurescan be enabled. The injection sites 520 for treating cosmetic conditionssuch as furrowed brows, crow's feet, or adding volume to lips can alsobe separately enabled. Once the testing tool 110 injects that particularinjection site 520 corresponding to the cosmetic condition, the camera120 views the injection and communicates the results to the processor604. The results are generated and displayed through the user interfacedevice 140.

FIG. 6 depicts further detail of the camera 120. The processor 604controls the various functions of the camera 120 and the camerainterface 605. The camera interface 605 can include, for example, anoptional output display 606, optional speaker driver 607, optionalspeaker 608, optional wired or wireless communication transceiver 609,optional user input 610, and on/off switch 611. The processor 604 cantransfer data to the output display 606, including display updates andvisual alarms. The processor 604 can also be configured to interpretuser inputs from the user input 610. The camera interface 605 mayreceive information from the user input 610 and send the user input datathrough the processor 604 so that the display data generated on theoutput display 606 can change according to a user's selection throughthe user interface device 140. The processor 604 may generate variousalarm signals when the user is in the testing or training mode of theinjection apparatus 100. The processor 604 controls a speaker driver 607which then actuates a speaker 608 to provide real-time informationregarding a user's progress for injections. The speaker 608 may provideaudible indications, allowing the user to know when an accurate orinaccurate injection has been made. For example, the speaker 608 mayemit a buzz sound when the injection is inaccurate and a beep sound whenthe injection is accurate.

The camera 120 receives its power from batteries in the camera orthrough a power supply 602. A power manager 603 monitors the on/offswitch of the camera 120 and the output device 140 and turns each on oroff accordingly. The batteries in the camera 120 may either be alkalinerechargeable batteries or another renewable power source. The camera 120may also be powered with a plug in cable. In some embodiments, thecamera can send information over a wireless network or directly toportable computer to process information about an injection using thewireless communication transceiver 609. The wired or wirelesstransceiver 609 can communicate over any known protocol includingBluetooth, Zigbee, WiFi, Ethernet, USB, or any other wired or wirelesscommunication protocols.

A non-volatile memory 600 is connected to the processor 604 via ahigh-speed bus. In the present embodiment, the memory 600 is erasableand allows a user to store information including operating software,user configurable command options and information related to differenttypes of injections, including recorded images or video. The memory 600may also store user-specific data. For example, a user who has completedseveral injections on a certain day may store results of those severalinjections and access the results at a later time. In addition,information obtained by the injection apparatus can be stored and sentto a central repository for analysis with testing information from otherdevices. The central repository, can be, for example, a server or cloudcomputing device.

FIG. 7 illustrates a view of one embodiment of the injection apparatus100 with a removable band 700. The removable band 700 allows forreplacement of portions of the injection apparatus without the need toreplace larger portions 720 of the simulated tissue. Multiple differentremovable bands can also be used. For example, a forehead band can beused in conjunction with a separate cheek skin band. In someembodiments, a removable band 700 may be placed on the base layer 400 ofthe injection apparatus 100. These embodiments allow a user to replaceonly the targeted injection areas. The removable band 700 may be placedon any portion of the injection apparatus 100. For example, testing foran injection involving cardiac treatment may require a removable bandbeing placed over the area of the simulated heart that needs treatment.The removable band 700 may have layers of simulated human skin or muscle700 attached. Each separate layer of skin or muscle 700 may be of adifferent transparency, density, or color. In some embodiments, theopaque layer obscures light from the needle portion of the testing tool110 being inserted through shallower layers or muscle or skin 700 frombeing viewed by the camera. For example, in an embodiment with threelayers of muscle or skin, the top layer may be opaque, the middle layermay be tinted red, and the bottom layer may be green and tinted. In someembodiments, the layers may be composed of material with differentangled threaded material. This angled threading will deflect the lightemitted from a testing tool in different directions so that the cameramay capture the depth, pressure, and angle of a user's injection.

FIG. 8 depicts an exploded view of an embodiment of a removable band 700which can be used in conjunction with the injection apparatus. In thisparticular embodiment, there are three layers of the removable band 700which are visually exploded for explanatory purposes. The layers 800,810, 820 may consist of different materials, colors, or angledthreading. For example, in FIG. 8, the first layer 800 may be made of atransparent elastomer layer with surface lines that are based in a rightdirection. The second layer 810 may consist of a transparent elastomerlayer with surface lines that are based in a left direction. The thirdlayer 820 may be targeted with grid lines or windows that are outlinedor colored. In some embodiments, grid lines or targeted windows 830allow the camera to easily find a certain zone for injection. By sendingkeystroke data to the processor 604, the camera 120 may be easilyrotated and directed toward a target area of injection. The surfacelines on the different layers may represent the angled threading of eachlayer. The angled threading allows light emitted from the testing tool110 to be reflected in different directions so that the camera 120 maygather visual information about the injection and send it to a processor604. The processor 604 may then analyze the different angles projectedfrom the testing tool 110 and determine the accuracy of the user'sinjection.

FIG. 9 depicts a cross sectional view of a top skin layer 900 dividedinto three separate simulated human skin or muscle layers 900, 910, 920and being injected by a testing tool A, B, C. The camera 120 may betargeted toward an injection zone of A, B, and C and capture the visualinjection through video or photographs. In one embodiment, the testingtool 110 may emit an intensity of light that is attenuated differentlyas it penetrates different layers of skin or muscle. For example, nolight is detected by the camera 120 while the testing tool 110 has notmade contact with the skin layer (shown in A). The light detected by thecamera 120 when the testing tool 110 reaches the second layer of skinmay be a more intense and of a different color in comparison to A (shownin B). The light detected by the camera 120 when the testing tool 110reaches the third layer of muscle may be the most intense and of adifferent color in comparison to A and B (shown in C). In someembodiments, an unattenuated light may signal that the user haspenetrated through all the layers of skin and muscle and hit the bone ofthe injection apparatus 100.

In some embodiments, the separate simulated skin or muscle layers mayconsist of different angled fibers. As a result of these angled fibers,the light emitted from the testing tool 110 may be deflected indifferent directions. For example, the fibers present in the lowestlayer of simulated muscle or skin may be at a 45 degree angle, thesecond layer of simulated muscle or skin may be at a 60 degree angle,and the top layer of simulated muscle or skin may be at a 75 degreeangle. As the camera 120 views the emitted light from the testing tool,it is able to capture information about the injection into the layer ofmuscle or skin. The output device 140 may receive this information andgenerate a report determining the depth, pressure, or angle of theuser's injection.

FIG. 10 illustrates the progression of a testing tool 110 being injectedinto an injection apparatus 100. In this embodiment, the testing tool110 is shown as being inserted into a removable band 700 with threelayers of simulated skin or muscle. Although shown with respect to aremovable band embodiment, it is to be understood that this processapplies equally to all embodiments disclosed herein. The camera 120within the injection apparatus 100 can focus on the targeted injectionzone. In some embodiments, the camera 120 can record or take pictures ofthe actual injection and send this information to the processor 604 oroutput device 140. As the injection is placed within the differentlayers of simulated skin or muscle, the intensity, angle, color or othervisual indication of the light viewed by the camera 120 from the testingtool 110 may change. In other embodiment, other non-visible lightattenuation techniques can be used. In some embodiments that have angledthreading of the different layers, the camera 120 can capture fewer linedirections as the testing tool passes through each layer of simulatedskin or muscle. For example, there are multiple line directionsdisplayed when the testing tool 110 is injected into the first layer1010 of simulated skin or muscle (shown in 1010 a). There are fewerlines displayed when the testing tool 110 is injected into the secondlayer 1020 of simulated skin or muscle (shown in 1020 a). When thetesting tool 110 is injected into the deepest layer of simulated skin ormuscle, there are no line directions present (shown in 1030 a). The onlyvisual display to the camera 120 is of the light emitted from thetesting tool 110.

FIG. 11 illustrates a front view of an injection apparatus 100 forcosmetic training with cosmetic conditions labeled to correspondinginjection sites on a muscle layer 1100. The muscle layer 1100 isavailable for a trainee to view and study the nerves and muscles of theface, head and neck. In this particular embodiment, common facialaesthetic conditions corresponding to certain muscles are labeled on theinjection apparatus 100. In this particular embodiment, the chart 1010displays the injection units for Botox® corresponding to each injectionsite. For example, the targeted site 1 corresponds with the targetedmuscle, procerus. The trainee is required to inject 20 units of Botox®to remove furrow lines from this area. It may show units or may justshow the muscle targeted for injection. This type of visual display ofthe labeled injection apparatus and the chart 1010 displaying requiredinjection units is available through the user interface for eachdifferent condition treated. For example, the user interface may displaya different chart for epidural or cardiac injections. The chart 1010 canbe a separate paper or it can be displayed graphically on the outputdevice 140 as part of the training system.

FIG. 12 illustrates an injection apparatus 100 and output display 1220depicting the corresponding image of the injection apparatus 100. Theskin layer 1210 of the injection apparatus 100 is shown and targetedzones of injection 1200 are labeled on the surface. In some embodiments,the targeted zones of injection 1200 may be different shapes, bedistinguished by grid lines, or by color. The injection apparatus 100receives an injection from a testing tool 110 and a camera 120 capturesthe visual display of an injection and transfers the information to aprocessor 604 or the output device 140. The processor 604 or outputdevice 140 then analyzes the visual information and generates an outputwith detailed information regarding the parameters of the injection.This information is then displayed on the output device 1220. In someembodiments, the output device 1220 may detect information in real timeand display injection parameters to a user.

FIG. 13 is a flowchart illustrating one embodiment of a method forutilizing an injection apparatus 100. In block 1300, the output device140 receives input from the user regarding the action that the userwould like to perform on the output device 140. The output device 140may be programmed to facilitate several program modes. For example, theuser may select to enter either the training or testing mode for theoutput device 140. In block 1310, the output device 140 may communicatewith the processor 604 to retrieve stored information from memory 600.This information may include a pre-set injection test for a specifictreatment or a display of injection sites for learning purposes. Theuser may also access information related to previous injection tests fora particular user. In block 1320, the processor 604 can generate dataassociated with a selected mode. For example, when user selects thetraining mode, the processor 604 can retrieve information from memory600 about different types of injections to educate the user. Theprocessor 604 may also receive directions to engage in testing mode.This prompts the processor 604 to activate the camera 120 for injectiontesting purposes. In block 1330, the output device 140 may display theoutput corresponding to the selected mode. For example, the outputdevice 140 may display the results of a simulated injection or displayfeedback on the injection.

FIG. 14 is a flowchart illustrating one embodiment of a method forutilizing an injection apparatus 100 in a simulated injection test. Atblock 1400, the output device 140 receives user input to perform testingat a targeted injection site. At block 1410, this request is sent to theprocessor 604 which, in an optional embodiment, sends signals to acamera 120 to rotate to a targeted injection site. At block 1420, aninjection performed by a user through a testing tool 110 is detected bya camera 120. Information regarding the injection may be directlycommunicated by the testing tool 110 through either a cable or awireless connection to a processor 604. At block 1430, the camera 120records either a video or captures a photograph of the injection at thetargeted injection site. At block 1440, the video or photograph isanalyzed by the processor 604. The processor 604 is able to determineone or more injection parameters, such as, for example, the angle,depth, pressure, and location of the injection. At block 1450, theinjection parameters analyzed by the processor 604 is displayed on anoutput device 140.

FIG. 15 illustrates a user interface for injection training through aninjection apparatus 100. The main menu of the user interface allows auser to select different modes of operation (e.g., training mode,testing mode) and different features (e.g., view previous reports,settings). The main menu also allows the user to calibrate the injectionapparatus 100. Once the user has selected an option from the main menu,the user selects the submit button 1510 and proceeds to another displayof the user interface.

In order to maintain the overall performance of the injection apparatus100 in conjunction with the testing tool 110 and camera 120, acalibration device can be provided that will check the accuracy of thetesting tool 110 with respect to the camera output. This may becompleted either automatically after a set number of injections ormanually when requested by a user. In some embodiments, the accuracy ofthe testing tool 110 may be calibrated to have a better than about 0.5mm precision.

FIG. 16 illustrates an injection apparatus with a skin layer displayed.In some embodiments, the output device displays this information toallow the trainee and trainer to view the ideal injections for each skinlayer site. In some embodiments, the skin layer may be color coded andthe different sections of the skin may be removable or replaceable. Forexample, the skin layer may be sectioned into different target zones sothat a user may remove the skin layer of a targeted zone and observe theinjection results into the muscle layer of the training apparatus 100.

FIG. 17 illustrates an injection apparatus 100 for therapeuticneuromodulation training with the muscle layer 1400 displayed. Injectionsites are marked on the front view of the injection apparatus 100. Insome embodiments, the injection sites may be color coded to allow theuser to visualize targeted muscles.

The output device 140 may allow the user to rotate the display presentedbetween landscape and portrait views. The injection apparatus 100 mayalso be physically rotated and this rotation may be detected by theprocessor 604, which then sends a signal to the output device 140 torotate the image displayed. The output device 140 may receivecommunications sent from a testing tool 110 to the processor 604regarding this change in direction of the injection apparatus 100 anddisplay the change accordingly. In an embodiment, the image displayed isa three dimensional image. In another embodiment, two dimensional imagesare displayed.

FIG. 18 illustrates a output device 140 display of an injectionapparatus 100 for injection training with injection sites displayed on amuscle layer. The injection sites 1810 depicted on this embodiment ofthe injection apparatus include injection sites 1810 which correspond tothose locations targeting neuromodulation or cosmetic treatments,including, for example, fillers. Some filler injection sites may includethe forehead, temples, brows, superior sulcus, nose, tear troughs,lateral cheeks, medial cheeks, submalar area/bucal fat pad, malargroove, nasal labial folds, pre-auricular fossa, lateral mandible,pre-jowl sulcus, chin, lips, ears, marionette lines, fine linesthroughout the face, neckless lines or vertical lip lines. In someembodiments, these injection sites 1810 can be located at differentareas on the body that target the brain or nervous system. Thetreatments may include those related to gastric disorders, Parkinson'sdisease, or urologic disorders. These therapeutic conditions are notsolely related to resulting neuromodulation or cosmetic conditions, butmay be a combination of other conditions, such as nerve conditions orother physical problems.

FIG. 19 illustrates a output device 140 display of an injectionapparatus 100 for injection training with a muscle layer 1900 displayed.The injection sites 1910 are labeled according to their muscle name. Insome embodiments, the displayed injection apparatus 100 may havedifferent muscles illustrated with different colors. This allows thetrainee to easily visualize the locations of each muscle as well as howbig the muscle may be with respect to the rest of the human face. A useris able to access displays for different treatments with targetedmuscles or areas of injections highlighted or marked for the user'sreference. This display may be seen by a user at the end of a simulatedinjection testing so that the user may learn from any errors that weremade during the simulation.

FIG. 20 illustrates a output device 140 display of an injectionapparatus 100 with a muscle layer 2000 displayed and labeled. Theinjection sites 2010 are labeled according to the corresponding cosmeticflaws. In some embodiments, the injection apparatus 100 displayed on theoutput device 140 may show different conditions needed for treatment.For example, the output device 140 may display areas needing injectionsfor treating cardiac conditions on a heart. In an embodiment, the outputdevice 140 is equipped with multi-lingual capabilities and a user canselect a language from menu settings to be used by the output device140.

FIG. 21 illustrates the back view of an injection apparatus 100 fortherapeutic neuromodulation training 2100 with a human head, neck andupper torso. These injection sites 2110 correspond to locationstargeting neuromodulation treatments. The injection sites 2110 may bephysically marked on the injection apparatus 100 or only shown on theoutput device 140. The injection sites 2110 may be presented indifferent shapes and allow a camera placed within the injectionapparatus 100 to focus in on a targeted zone for different treatments.For example, the injection apparatus 100 may simulate the back of ahuman for epidural injections. The training apparatus may also simulatedifferent organs of the human body, such as the heart, brain, or liver.In one embodiment, the training apparatus may be covered in differentlayers of material for detecting an injection.

FIG. 22A illustrates the display of a mapped dermal filler injection andone embodiment of scoring the injection. As an injector is performing asimulated injection, the output device 140 can provide real-time displayof the desired and actual injection paths and dispersion volumes. Forexample, the output device 140 can show the target path for a dermalfiller 2210 and the actual path of the injection 2220 performed by theinjector. The output device 140 can also show the target volume 2230along a needle path and the actual volume 2240 of the injection. In someembodiments, the output device 140 may display other parametersassociated with the injection, such as the location of the needle 212when it is inserted into the injection apparatus 100, the force of theinjection, or the angle of the injection.

FIG. 22B illustrates the expanded view of a mapped dermal fillerinjection of FIG. 22A. In some embodiments, the camera 120 detects theactual path of the injection 2220. The various paths and injectionpoints may be displayed in various colors. The actual volume injectedinto the injection apparatus 100 may be calculated by measuring theposition of the testing tool plunger 209. The position and volumeaccuracy may be calculated and displayed by the output device 140.

FIG. 23 depicts a resulting output of an injection test on the outputdevice 140. The displayed apparatus 2200 has the muscle layer shown andinjection sites 2210. The process for displaying the output of thetesting results begins with the output device 140 receiving instructionsto simulate a pre-set cosmetic condition or therapeutic treatment. Inone embodiment, a user has the option to input requirements for aspecific injection. The individual being tested or trained can thenprepare the testing tool 110 with the injection product that correspondsto the cosmetic condition or therapeutic treatment. By utilizing thecamera 120 stored within the injection apparatus 100, the 3D coordinatesof an injection can be determined based on position and intensity of theattenuated detected light received from the testing tool 110 and/or inconjunction with location markings as described above. The processor 604or output device 140 may receive a wired or wireless signal detection ofthe 3D location, pressure, and angle of the injection on the injectionapparatus 100. The 3D coordinates of the testing tool can be used toevaluate the accuracy of the injection.

The results are displayed in a chart 2220 that informs a user oroperator of an injector's performance. The output device 140 or softwareapplication reports the parameters of the injection collected from thetesting tool 110 or camera 120. In some embodiments, the output device140 and/or software application provides feedback on the results. Forexample, the feedback may include whether the injection was made in thecorrect location, the depth of the injection, and areas in which theinjection could have been improved. In one embodiment, the feedback mayinclude whether a user passed or failed an injection test correspondingto a cosmetic condition or therapeutic treatment. The results may alsobe in the form of a score, accuracy rating, or an overall rating.

In this particular example of FIG. 23, the user failed the injectionstandard at injection sites 1, 4, and 5 and passed the injectionstandards at injection sites 2 and 3. The user may choose to view theresults in only the chart form or with indicators displayed on theinjection apparatus shown on the output device 140. For example, theindicators may be Xs or Os showing the accurate or inaccurateinjections.

After completing the injection test, the user may select a differentview of the injection apparatus 100 or choose to enter a learning modefrom the main menu 2250. The user has the option of starting over bypressing the new test button 2240 or printing the report 2230. The userinterface provides the user or operator with the option of saving theinjector's results into the software program for later access.

The test data and other data collected by the devices and systems of thepresent disclosure can also be analyzed using data analytics. Forexample, data analytics software can analyze data or informationcollected from and associated with patients and injectors who use theinjection apparatus 100. This data can be collected from a large numberof patients and injectors and compiled for analysis, or data can becollected and analyzed separately for each patient or injector. The datacan be stored in an electronic storage device local to the injector orat a remote location. In an embodiment, the injection records can beassociated with or collected from electronic medical records (EMR). Inan embodiment, the data associated with a patient or injector may beaccessible by linking the individual's information with a fingerprint orusername and password. The fingerprint may be read by a biometricsensor. In some embodiments, an injector may access his or her progresswhen performing injections on any injection apparatus and each trainingor test result may be stored. In some embodiments, the patient will havea compilation of all their medical information stored in a database thatcan be retrieved once their profile is accessed on a output device 140.The information may include personal information, medical history, andtypes of procedures which have been performed on the patient, which, forexample, can be stored in the form of an EMR. Injectors who use theinjection apparatus 100 may include those who are certified, are in theprocess of being certified, doctors, nurses, or other medicalpractitioners.

The software may keep track of an injector's progress of injectionsperformed on the injection apparatus. Based on the injector'sperformance, there may be a score, rating or ranking calculated andpresented to a user requesting information on the injector. The score,rating or ranking provides an indication of an accuracy of theinjections performed, an estimated skill level of the injector, anindication of the experience of the injector or the number of injectionsperformed, or any other measure indicative of the quality of theinjector. A separate score or ranking may be available for differenttypes of injections or injection locations. For example, a usersearching for an injector experienced in treating crow's feet may pullup a list of injectors in a geographic area. The injectors may be listedby ranking, rating or score based on one or more of education, years ofexperience, performance results with the injection apparatus, or patientreviews. The data can also be collected from multiple patients orinjectors and analyzed to determine a bulk average. This can be used todetermine the effectiveness of a treatment or the risks associated withtreatment.

FIG. 24 depicts an injection apparatus 100 for injection or open brainsurgery training with a simulated human (or animal) brain 2410 displayedand labeled. In some embodiments, an injector is able to practice brainsurgeries requiring removal of skin and bone. For example, an injectormay perform a craniotomy, where the bone flap is temporarily removed andthen replaced after brain surgery. Craniotomy procedures may beperformed for brain tumors, aneurysms, blood clots, removingarteriovenous malformation, draining brain abscess, repairing skullfractures, repairing tears in the brain lining, relieving brainpressure, or epilepsy. In performing simulated open brain surgerytraining, the injector may surgically remove a portion of the skin,muscle, or skeletal layers 2400 of the injection apparatus 100. Thedifferent portions of the simulated human brain 2410 may be color codedor have varying densities. Different colors, directions, or intensitiesof light can be captured by the camera 120 as the testing tool 110 isinjected through the different sections of the human brain 2410. Theinjector also may remove a portion of the human brain 2410 in order tosimulate performing a biopsy.

In some embodiments, the testing tool 110 may be a scalpel or otherequipment used for incisions. The resulting colors, directions,intensities or other visual effects of light detected by the camera 120represent the location, differences in pressure exerted by the user,angle of injection, or the depth of the injection. This information canbe detected, for example by a camera 120, and communicated to a userinterface device 140 for testing or certification purposes. The camera120 may be an endoscope so it may fit within the simulated human brain2410 or other simulated organs which may not be capable of containing abigger camera 120. An endoscope may be used for training procedures onother organs, such as the bladder, ureters, or kidneys. The camera 120is able to detect the size and location of the portion which is removedfrom the injection apparatus 110. Alternatively, only a portion of thebody part is provided and an opposing portion is left open so that acamera can be positioned to detect the testing tool. For example, inFIG. 23, the fact can be left open so that a camera can be positioned toview the opposite side of the brain from an injection or treatment site.

At the end of the simulated operation, the injector or therapist mayreturn the removed portion of the skin, muscle, or skeletal layers 2400into the simulated human brain 2410. This can be accomplished byattaching the skin incision to the injection apparatus 110 with suturesor surgical staples.

In some embodiments, the injection apparatus 100 may be used inconnection with non-invasive or minimally invasive surgical techniqueswhich do not require incisions or do not require large incisions. Forexample, an injector may be able to perform a simulated brain surgerywith radiation, where a high dose of radiation is applied to problematicnerves. This does not require the injector to open up the injectionapparatus 100 to view the simulated human brain 2410, but still allowsthe injector to practice this technique by using the output device 140to view the simulated human brain 2410.

FIG. 25 depicts an injection apparatus for injection or eye surgerytraining with a human eye 2500 displayed. The injection apparatus may beused for therapeutic eye treatment, such as age-related maculardegeneration. Injectors may perform anti-vascular endothelial growthfactor injection therapy on the simulated human eye 2500. In someembodiments, the injector may be required to numb the simulated humaneye 2500 and clean it with antiseptics as part of the trainingprocedure. Other procedures may include performing cataract surgery,glaucoma surgery, intravitreal Kenalog injections, or canaloplasty.

In some embodiments, the camera 120 may be placed within the injectionapparatus and focused on the simulated human eye 2500. The camera 120may also be an endoscope that captures the administered injection orsurgical procedure. In some embodiments, the coats or sections of theeye may be have a different color or density. For example, fibrous tunicmay be opaque, the vascular tunic or uvea may be tinted, and the retinamay be clear. Once an injection is placed by the injector into the eye,the camera 120 may detect the parameters of the injection.

FIG. 26 illustrates an injection apparatus for injection or spinalsurgery training with a human spine 2600 displayed. The camera 120 maybe placed within the injection apparatus 100 so that it is may move andfocus on specific sections of the human spine 2600. The injectionapparatus may be used for practicing spinal procedures, such as lumbarnerve root sleeve, radiculography, lumbar facet infiltrations,ligamentary infiltration on the sacroiliac joint, lumbar epidural paintherapy, epidural-sacral epidural-dorsal, or epidural perineuralinjections. In some embodiments, the different segments of the spine maybe of a different color or density. The camera 120 may detect the angleof the spinal injections, which is particularly important in identifyingsuccessful spinal procedures.

FIG. 27 illustrates an injection apparatus for injection training withthe anatomy of a dog 2700 displayed. The injection apparatus maysimulate the entire body of an animal or only a specific section of thebody or any internal organs. Cameras 120 may be placed within theinjection apparatus at different locations of the dog body 2700. Thetraining apparatus may be used to practice inserting intravenous,central line, or arterial catheters into the dog 2600. Injectors mayalso use the training apparatus for performing procedures on extractingfluids from internal organs. For example, the injector may practicecystocentesis, abdominocentesis, pericardiocentesis, thoracentesis, ormyelograms. collecting data analysis present disclosure, various doctorsand practice procedures and can

In some embodiments, the veins of a dog 2700 may have a different coloror density than the other portions of the injection apparatus. This isparticularly helpful for injectors who wish to practice intravenousinjections. For example, injectors who want to practice euthanasiaprocedures may be given a solution that has the same viscosity ofpentobarbital or phenytoin, which are commonly used by veterinarian inadministering euthanasia procedures.

FIG. 28 depicts an injection apparatus for injection training with theanatomy of a rat 2800 displayed. For smaller injection apparatuses, anendoscope may be used as the camera 120. The different organs orsections of the rat 2800 may be color coded or be of a differentdensity. In some embodiments, portions of the rat may be surgicallyremoved for procedures to simulate a biopsy.

Alternative Embodiments

In some embodiments, an injection training apparatus or method using oneor more 3D position sensors for determining a position of a syringeand/or needle in an artificial patient injection site (such as, forexample, an artificial face) can be used. In addition to the methodsdescribed above, 3D position sensor can also be used for trainingcaregivers on performing injections where accurate positioning isimportant, such as in facial injections (e.g., Botox®), spinalinjections, and/or the additional injections described above.

By integrating one or more 3D sensors, the injection training apparatusand method may provide enhanced accuracy when tracking the trainee'sinjection technique. Increased training accuracy can facilitateincreased detail on the feedback provided to the trainee. The featuresdiscussed below with reference to FIGS. 29-35 may be included, in wholeor part, with the training systems, methods, and devices describedabove.

FIG. 29 illustrates a further embodiment of the injection apparatus,testing tool and output device. The injection apparatus 2900 shown formsa head bust with realistic look and feel of human flesh. The externalsurface of the injection apparatus 2900 may be a substantially syntheticor simulated skin. The synthetic or simulated skin can be an opaquerubber or other material which simulates skin and facial features ofreal patients. Underlying the skin may be a layer of substantially clearrubber (and/or any suitable elastomer) which simulates the viscosity andfeel of skin, muscle, nerve and bone tissue of a patient. The opaqueskin and clear underlay may be pierce-able by a needle. It should benoted that the injection apparatus 2900 need not include coloredunderlying skin to attenuate light.

The injection apparatus 2900 is hollow and includes, within the cavity,a three-dimensional (3D) sensor 2902. The 3D sensor 2902 may include acamera, array of light detectors or other sensor(s) capable of detectinga location of an object in three dimensions. The 3D sensor 2902 isconfigured to detect a position of a needle and/or to view the interiorsurface of the injection apparatus 2900. A field of view 2904 isestablished in front of the 3D sensor 2902. The field of view 2904represents an area in which the 3D sensor 2902 may detect light.

A testing tool 2950 is also shown. The testing tool 2950 may beimplemented as a syringe equipped with a light emitting needle. Thelight emitted by the testing tool 2950 may be detected by the 3D sensor2902.

As shown in FIG. 29, the 3D sensor 2902 and the testing tool 2950 arecoupled with a signal processing and display interface 2955. Thecoupling may be via wired, wireless, or hybrid wired-wireless means. Themethod of coupling the 3D sensor 2902 need not be identical to themethod of coupling used for the testing tool 2950.

In use, a trainee punctures the face of the injection apparatus 2900with the testing tool 2950 which is emitting light from the needle tip.When the needle tip passes through the opaque skin layer of theinjection apparatus 2900, the 3D sensor 2904 is configured to detect thelight from the needle tip and determine an X-Y-Z position of the needletip. The X-Y-Z position information is transmitted to the signalprocessing and display interface 2955. The signal processing and displayinterface 2955 is configured to integrate the position information intothe digital model of the head bust. The signal processing and displayinterface 2955 is configured to communicate with a display device 2960.The display device 2960 may be configured to present a visualrepresentation of the needle tip position vis-à-vis the injection site.The display device 2960 allows the trainee to gauge the actual needleposition in comparison to the ideal position. The display device 2960shown in FIG. 29 is coupled with the signal processing and displayinterface 2955. The coupling may be via wired, wireless, or hybridwired-wireless means.

The X-Y-Z position information relative to the 3D sensor 2902 is mappedin software to graphical representation of the injection site on thedisplay. This mapping is performed by first determining exact3-dimensional dimensions of the injection apparatus 2900. The positionof the 3D sensor 2902 relative to the rest of the injection apparatus2900 is also determined with a high degree of precision. This precisionallows a very accurate mapping of the detected X-Y-Z positioninformation of the syringe tip to be accurately detected by the 3Dsensor 2902 and accurately mapped in software to recreate the positionof the syringe tip. This information is then used to determine both theaccuracy of the injection relative to a predetermined injection siteaccuracy goal as well as provide a graphical illustration of theinjection, again relative to the injection site goal. This mapping anddisplay can be provided substantially in real time so that a user canadjust the trajectory of their injection during the training.

FIGS. 30A and 30B illustrate two views of a trajectory for an injection.FIG. 30A is a view taken from the 3D sensor 2902 perspective inside theinjection apparatus 2900 of the inner surface. To orient the reader, aneye 3002 and a nose 3004 have been labeled. An injection starting point3010 is detected by the 3D sensor 2902. As the needle tip proceeds intothe injection apparatus 2900, the positions of the light emitted fromthe needle tip are measured by the 3D sensor 2902. In someimplementations, the measurement may be a video capture of theinjection. In some implementations, the measurement may be a sampledcapture at, for example, predetermined intervals. A trajectory path 3030from the starting point 3010 to an ending point 3020 is thus obtained.As shown in FIG. 30A, the trajectory path 3030 is not a straightinjection path, which may, in some circumstances, indicate the need foradditional training.

The trajectory path 3030 may be presented via the display 2960. Thepresentation may include providing a line tracking the injection path.The presentation may include providing an animated depiction of theinjection. In some implementations, the presentation may be augmentedwith additional information such as identifying and showing whichmuscles, skin, body parts, etc. the injection is penetrating. Theaugmentation may retrieve one or more models of the desiredphysiological information from a data store. The models include threedimensional information indicating the location(s) of the features. Thefeature information along with the three dimensional injection locationinformation is mapped onto the model of the injection apparatus.

Because three-dimensions of information are being obtained, multipleviews of the injection trajectory may be provided. FIG. 30B provides asecond view of the injection trajectory shown in FIG. 30A. FIG. 30Billustrates a view taken from an overhead perspective of a horizontalcross-section of the injection apparatus 2900. The cross-section istaken at a point on the injection apparatus 2900 which allows the viewerto see a horizontal injection trajectory path 3060 of the needle. As inFIG. 30B, to orient the reader, the eye 3002 and the nose 3004 have beenlabeled.

The horizontal injection trajectory path 3060 begins at the startingpoint 2010 and ends at the ending point 3020. However, because theperspective has changed, the shape of the path 3060 is different thanthat shown in FIG. 30A. This provides another view of the injectionresult. It will be understood that the model may be arbitrarily rotatedand a representation of the trajectory path for the model, as rotated,may be generated. The rotation may be provided to the system as adisplay point of view identifying the location in space from which toview the trajectory path. Because the injection apparatus digital modelis combined with the three dimensional injection information and, insome instances, physiological information, the injection training mayprovide a wide variety of views depending on the technique needed forthe injection. The views may be provided as animated depictions such asvideo or reconstructed animations.

The aspects shown in FIG. 29 allow a trainee to adjust their techniqueand monitor their progress toward the ideal injection technique. Forexample, the display device 2960 may provide a view selector (not shown)to allow the trainee to see the injection site from a variety of viewssuch as rotated, zoomed in, zoomed out, cross-sectional, time-lapsed,and the like, both in real time and after the injection has occurred. Asshown in FIG. 29, a cross sectional view is displayed whereby thetrainee can see how far through an opaque skin layer 2990 into a clearmaterial layer 2992 the testing tool has passed.

In some implementations, the X-Y-Z position information received fromthe 3D sensor 2904 may be converted before integration into the digitalmodel of the injection apparatus 2900. In such implementations, thereceived X-Y-Z position information may be calibrated, adjusted, orotherwise converted such that the position information of the testingtool 2950 may be correlated with a position on the digital model of theinjection apparatus 2900.

As discussed, one or more sensors may be provided within the trainingapparatus 2900 which provide three-dimensional position information forthe testing tool 2950. FIG. 31 illustrates an example of a 3D injectiondetection sensor. A dimensional legend 3199 is provided indicate thethree axes (e.g., X, Y and Z) of detection. This dimensional legend 3199is logical and may not physically be included in an embodiment of theinjection training systems described. The names attributed to each axismay differ, but each axis should represent one unique dimension.

The 3D injection detection sensor 3100 is shown receiving light from atesting tool at a first position 3102 and then at a second position3104. These positions are not simultaneous, but rather represent themovement of the testing tool over time. The light emitted from thetesting tool is received by the 3D injection detection sensor 3100. Thelight is emitted from the tip of the testing tool and disperses enrouteto the 3D injection detection sensor 3100. As shown in FIG. 31, a firstarea of light 3110 is generated when the testing tool is located at thefirst position 3102. A second area of light 3112 is generated at asecond time when the testing tool is located at the second position3104. The 3D injection detection sensor 3100 may be configured tomeasure one or more characteristics of the received area light andgenerate the three dimensional location information based in thecharacteristics detected. The characteristics may include angle,intensity, brightness, color, dispersion, and/or duration of the light.

In one implementation, the 3D injection detection sensor 3100 mayinclude an array of light sensors. As light is emitted from the needletip, one or more of the sensors in the array may receive light. Byaggregating the information about which sensors received light andcharacteristics of the light received at each sensor, three-dimensionalinformation about the location of the light source may be determined.Some 3D injection detection sensors may be housed in a recess and, basedon the light pattern cast on the sensor, determine the location of thelight source. In generating the 3D location information, the 3Dinjection detection sensor 3100 may also obtain calibration informationfor the needle tip to account for variability such as in manufacturing,wear-and-tear, and power. Further calibration information may be used tospecify the field of view for the 3D injection detection sensor 3100.The calibration information may be received, for example, through aninitialization sequence whereby the testing tool is placed at apredetermined location on the injection apparatus.

Because the 3D injection detection sensor 3100 knows the light sourceand its particular location vis-à-vis the light source, the 3D injectiondetection sensor 3100 can generate accurate and, in someimplementations, real-time 3D location information for the testing tool.

FIG. 32 illustrates another example of a 3D injection detection sensor.It may be desirable to implement the 3D injection detection sensor as astereoscopic sensor pair. A dimensional legend 3299 is provided indicatethe three axes (e.g., X, Y and Z) of detection. This dimensional legend3299 is logical and may not physically be included in an embodiment ofthe injection training systems described. The names attributed to eachaxis may differ, but each axis should represent one unique dimension.

The sensor pair includes a first sensor 3202 and a second sensor 3204.The first sensor 3202 and the second sensor 3204 are configured toreceive, at substantially the same time, light from a testing tool. Thetesting tool may be located at different positions. FIG. 32 shows afirst position 3210 and a second position 3212 at a second time for thetesting tool.

Each sensor is configured to measure one or more characteristics of thelight transmitted from the testing tool position and generate the threedimensional location information based in the characteristics detected.The characteristics may include angle, intensity, dispersion,brightness, color, duration of the light. Combining the characteristicdata received from the first sensor 3202 and the second sensor 3204,three dimensional information for the testing tool may be generated. Thecombination may be performed by one of the sensors or by the signalprocessing and display interface 2955.

In generating the 3D location information, the generation of thethree-dimensional information may also include obtaining calibrationinformation for the needle tip to account for variability such as inmanufacturing, wear-and-tear, and power. The calibration information maybe received, for example, through an initialization sequence whereby thetesting tool is placed at a predetermined location on the injectionapparatus.

FIG. 33 depicts a side view of one embodiment of the injection apparatusincluding a 3D injection detection sensor. The injection apparatus 3300is formed as a human head. A testing tool 3302 is shown inserted intothe injection apparatus. The testing tool 3302 may be implemented asdescribed above such as in reference to FIG. 2A, 2B, 2C, 2D, or 3. Tominimize diffraction of the light emitted from the testing tool 3302, asurface of clear elastomer 3310 may be made perpendicular to thedirection of light travel. Accordingly, in an embodiment the innersurface of the clear elastomer is formed as a spherical surface with thecenter facing a 3D sensor 3304. The 3D sensor 3304 may be implemented asdescribed above such as in reference to FIGS. 30 and 31. The 3D sensor3304 is configured to detect light emitted by the testing tool 3302within a field of view 3306.

Rather than utilize a light emitting testing tool in combination with asingle 2D camera that detects the X-Y position of the light emittingneedle tip, the injection training apparatus may include 3D sensorsand/or tracking equipment. With a single 2D camera a Z position may bedetermined, for example, by tinting the clear elastomer layer, causing acolor of the light to change as the needle tip transitions through thetinted layer. For example, the color may trend toward white light as theneedle tip move closer to the inner surface of the clear elastomer.

It may be desirable to avoid tinting the clear elastomer layer and allowthe use of 3D tracking equipment, such as 3D cameras and sensors,examples of which are shown in FIGS. 31 and 32 above. Further examplesof 3D tracking equipment include equipment sold by Personal SpaceTechnologies B.V. (available at http://ps-tech.com/). Additionalexamples of 3D tracking equipment may be found athttp://en.wikipedia.org/wiki/3D_computer_vision andhttp://www.csem.ch/site/SpaceCoder/doc/Scientific_Report.pdf, each ofwhich is incorporated by reference herein.

As the testing tool 3302 penetrates an opaque skin layer 3308 and entersthe internal clear elastomer layer, the 3D sensor 3304 detectscharacteristics of the light which can be used to generate a threedimensional location of the testing tool 3302. For example, it may bedesirable to track a desired range 3312 of needle penetration. In someimplementations, the depth information is displayed on a display, suchas the display 2960, as the testing tool 3302 is inserted. This allows atrainee to visualize where the injection is in near real-time. Thesignal processing and display interface 2955 may provide the locationinformation to facilitate such displays. In some implementations, thefeedback may be provided in audio form such as a beep or alert.

FIG. 34 shows a process flow diagram of a method of manufacturing ananatomically shaped injection apparatus including a 3D tracker such asthat shown in FIG. 33. The method includes, at block 3402, forming an atleast partially hollow base configured to provide structural support fora target injection test area. The method includes, at block 3404,coating at least a portion of the base with a clear layer of elastomer.The method also includes, at block 3406, coating at least a portion ofthe clear layer with an opaque layer. The base, clear layer, and opaquelayer form an anatomical shape such as a skull. The method furtherincludes, at block 3408, affixing a three-dimensional (3D) trackingsystem within a hollowed portion of the base, wherein thethree-dimensional tracking system provides a field of view of the clearlayer covering the target injection test area. The three dimensionaltracking system may be a 3D camera such as that shown in FIG. 31 or astereoscopic camera pair such as that shown in FIG. 32. In someimplementations, the method may also include coupling the 3D trackingsystem with a location processor configured to provide locationinformation for a light source inserted into the clear layer. Thelocation information identifies a three-dimensional location of thelight source relative to the injection training apparatus. The locationprocessor may be implemented as the signal processing and displayinterface 2955 shown in FIG. 29.

FIG. 35 illustrates a process flow diagram for a method ofthree-dimensional (3D) injection training. The method may be performedin whole or in part by one or more of the devices described herein suchas the training apparatuses described above.

The method includes, at block 3502, calibrating at least one of a lightsource and a three-dimensional tracking system. The light source may bea light emitter located at the tip of a testing tool. Thethree-dimensional tracking system may include a 3D camera, astereoscopic camera pair, or other sensor configured to provide threedimensional location information for the light source. The method alsoincludes, at block 3504, detecting, by the three-dimensional trackingsystem, a characteristic of light emitted from the light source for aninjection. The characteristic may include intensity, angle, dispersion,brightness, color, and duration of the light. In some implementations,an array of sensors may be used to detect light. In suchimplementations, the characteristic may include which sensors receivedlight. The method further includes, at block 3506, generatingthree-dimensional location information of the light source based on thedetected characteristics and said calibrating.

TERMINOLOGY/ADDITIONAL EMBODIMENTS

The term “injection” as used herein includes it usual and customarymeaning of an injection, but is also to be interpreted broad enough toencompass, for example, the insertion of a catheter device or the use ofsimple needles, such as would be used in an acupuncture therapy. Thetechniques involved, particularly a camera embedded in a model of aliving subject and a tool with a light emitter can be applied to anytherapeutic procedure. For example, the tool can be a catheter and theprocedure can be a minimally invasive procedure requiring the catheterto be located in a particular location.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orstates. Thus, such conditional language is not generally intended toimply that features, elements and/or states are in any way required forone or more embodiments or that one or more embodiments necessarilyinclude logic for deciding, with or without author input or prompting,whether these features, elements and/or states are included or are to beperformed in any particular embodiment.

Depending on the embodiment, certain acts, events, or functions of anyof the methods described herein can be performed in a differentsequence, can be added, merged, or left out altogether (e.g., not alldescribed acts or events are necessary for the practice of the method).Moreover, in certain embodiments, acts or events can be performedconcurrently, e.g., through multi-threaded processing, interruptprocessing, or multiple processors or processor cores, rather thansequentially.

The various illustrative logical blocks, modules, circuits, andalgorithm steps described in connection with the embodiments disclosedherein can be implemented as electronic hardware, computer software, orcombinations of both. To clearly illustrate this interchangeability ofhardware and software, various illustrative components, blocks, modules,circuits, and steps have been described above generally in terms oftheir functionality. Whether such functionality is implemented ashardware or software depends upon the particular application and designconstraints imposed on the overall system. The described functionalitycan be implemented in varying ways for each particular application, butsuch embodiment decisions should not be interpreted as causing adeparture from the scope of the disclosure.

The various illustrative logical blocks, modules, and circuits describedin connection with the embodiments disclosed herein can be implementedor performed with a general purpose processor, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield programmable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor can be a microprocessor, but in thealternative, the processor can be any conventional processor,controller, microcontroller, or state machine. A processor can also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors, one ormore microprocessors in conjunction with a DSP core, or any other suchconfiguration.

The blocks of the methods and algorithms described in connection withthe embodiments disclosed herein can be embodied directly in hardware,in a software module executed by a processor, or in a combination of thetwo. A software module can reside in RAM memory, flash memory, ROMmemory, EPROM memory, EEPROM memory, registers, a hard disk, a removabledisk, a CD-ROM, or any other form of computer-readable storage mediumknown in the art. An exemplary storage medium is coupled to a processorsuch that the processor can read information from, and write informationto, the storage medium. In the alternative, the storage medium can beintegral to the processor. The processor and the storage medium canreside in an ASIC. The ASIC can reside in a user terminal. In thealternative, the processor and the storage medium can reside as discretecomponents in a user terminal.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the devices or algorithms illustrated can be madewithout departing from the spirit of the disclosure. As will berecognized, certain embodiments of the disclosures described herein canbe embodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others. The scope of certain disclosures disclosedherein is indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. An anatomically shaped injection trainingapparatus comprising: an at least partially hollow base configured toprovide structural support; a clear layer of elastomer coating at leastpartially covering a base layer; an opaque layer at least partiallycovering the clear layer, wherein the base, clear layer, and opaquelayer form an anatomical shape; and a three-dimensional (3D) trackingsystem positioned inside the base and configured to determine a locationof a needle inserted into the clear layer of elastomer.
 2. The apparatusof claim 1, wherein a light is emitted from the needle.
 3. The apparatusof claim 1, wherein the 3D tracking system is further configured totrack multiple locations of the needle over time.
 4. The apparatus ofclaim 1, wherein the 3D tracking system comprises a camera.
 5. Theapparatus of claim 1, wherein the 3D tracking system comprises astereoscopic pair of cameras.
 6. The apparatus of claim 1, wherein the3D tracking system comprises an array of light sensors.
 7. The apparatusof claim 1, wherein the 3D tracking system is configured to determinethe location of the needle based on a measurement of one or morecharacteristics of an emission from the needle.
 8. The apparatus ofclaim 7, wherein the emission is light, and wherein the characteristicsinclude intensity, angle, dispersion, brightness, color, and duration ofthe light.
 9. The apparatus of claim 1, wherein the location of theneedle with respect to an injection site on the apparatus is transmittedfor display via an electronic display.
 10. The apparatus of claim 9,wherein the electronic display is configured to display the indicationof the detected light from the light detector.
 11. The apparatus ofclaim 10, wherein the indication of the detected light is an image. 12.The apparatus of claim 9, wherein the indication of the detected lightis an animated depiction of the needle passing through the injectionsite.
 13. The apparatus of claim 12, wherein the animated depiction is astored video of the needle passing through the injection site.
 14. Theapparatus of claim 12, wherein the animated depiction is generated basedon a stored plurality of locations for the needle.
 15. The apparatus ofclaim 14, wherein the animated depiction is further generated based on adisplay point of view, the display point of view identifying a virtuallocation in space from which to view the animated depiction.
 16. Theapparatus of claim 9, wherein the display device is configured todisplay injection measurement data.
 17. The apparatus of claim 1,wherein the opaque layer is configured to represent one or more ofdifferent ages, ethnicities, races, textures, or thicknesses of humanskin.
 18. A method of manufacturing an anatomically shaped injectiontraining apparatus, the method comprising: forming an at least partiallyhollow based configured to provide structural support for a targetinjection test area; coating at least a portion of the base with a clearlayer of elastomer; coating at least a portion of the clear layer withan opaque layer, wherein the base, clear layer, and opaque layer form ananatomical shape; and affixing a three-dimensional (3D) tracking systemwithin a hollowed portion of the base, wherein the three-dimensionaltracking system provides a field of view of the clear layer covering thetarget injection test area.
 19. The method of claim 18, wherein affixingthe 3D tracking system comprises affixing a 3D camera within thehollowed portion of the base.
 20. The method of claim 18, whereinaffixing the 3D tracking system comprises affixing a first camera and asecond camera within the hollowed portion of the base, wherein a centerpoint of said first camera is aligned with a center point of said secondcamera, and said first camera and said second camera are configured as astereoscopic camera pair.
 21. The method of claim 18, further comprisingcoupling the 3D tracking system with a location processor configured toprovide location information for a light source inserted into the clearlayer, said location information identifying a three-dimensionallocation of the light source relative to the injection trainingapparatus.
 22. The method of claim 18, wherein the anatomical shapecomprises a human skull shape.